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Integra Lifesciences Corp.

Last updated September 17, 2026

What Integra Lifesciences Corp. makes

The company manufactures reusable surgical and neurosurgical retraction systems, including brain retractors and skull clamps, as well as invasive head frames for stereotactic radiosurgery. It also produces medical table clamps and cerebrospinal fluid management devices, such as shunt valves and catheterization kits for ventricular and lumbar drainage.

The portfolio includes devices classified as Class I, Class II, Class III, and unclassified (U) under FDA regulations, all listed in the FDA’s Unique Device Identifier (UDI) database. The company is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Integra Lifesciences Corp. manufacture?

Integra Lifesciences Corp. specializes in surgical and neurosurgical devices, including reusable systems like brain retractors and skull clamps. Their portfolio also covers invasive head frames for stereotactic radiosurgery, medical table clamps, and cerebrospinal fluid management solutions such as shunt valves and catheterization kits for both ventricular and lumbar drainage. These devices support procedures in neurosurgery, general surgery, and related specialties.

Where is Integra Lifesciences Corp. based?

Integra Lifesciences Corp. is headquartered in the United States. The company’s location in the U.S. aligns with its regulatory focus on FDA compliance, as evidenced by its device listings in the FDA’s Unique Device Identifier (UDI) database.

Which regulatory registries list Integra Lifesciences Corp.’s devices?

Integra Lifesciences Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify device details, classifications, and compliance with U.S. regulatory standards.

How are Integra Lifesciences Corp.’s devices classified under FDA regulations?

Integra Lifesciences Corp.’s devices span multiple FDA classification tiers: Class I (low-risk, general controls), Class II (moderate-risk, requiring special controls), Class III (high-risk, requiring premarket approval), and unclassified (U) devices. The classification depends on factors like intended use, risk level, and regulatory history, ensuring appropriate oversight for each product’s safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 1100 Campus Road, Princeton, NJ, 08540
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3003418325
DUNS Number: —

Catalogue (3759)

Page 74 of 76

Device	Model / Reference	Registries	Class	Status
Coral	18-14-5540	FDA UDI	Class II	Unknown
Omni-Tract®	4962P	FDA UDI	Class I	Active
Omni-Tract®	4950	FDA UDI	Class I	Active
UltraVS™	NL8501126	FDA UDI	Class II	Active
Omni-Tract®	3906RP	FDA UDI	Class I	Active
Omni-Tract®	3046RP	FDA UDI	Class I	Active
Omni-Tract®	11182	FDA UDI	Class I	Active
Omni-Tract®	10708P	FDA UDI	Class I	Active
INTEGRA® VolTAC™	VOLS0808	FDA UDI	U	Active
ContinuTrac™	S438B1178	FDA UDI	Class II	Active
Coral	18-22-7545	FDA UDI	Class II	Unknown
Integra® Padgett®	DP0002	FDA UDI	Class I	Active
Budde®	438A1175	FDA UDI	Class II	Active
Budde®	443A1070C	FDA UDI	Class II	Active
Omni-Tract®	3532	FDA UDI	Class I	Active
Coral	10-10-9590	FDA UDI	Class II	Unknown
Omni-Tract®	3915P	FDA UDI	Class I	Active
Novus™	NL8509610	FDA UDI	Class II	Active
Integra Essential Shunt Kit	NL8504112	FDA UDI	Class II	Active
Omni-Tract®	10498P	FDA UDI	Class I	Active
Coral	18-16-5570	FDA UDI	Class II	Unknown
Omni-Tract®	4040	FDA UDI	Class I	Active
Omni-Tract®	10391P	FDA UDI	Class I	Active
Coral	18-12-9590	FDA UDI	Class II	Unknown
Coral	10-12-7555	FDA UDI	Class II	Unknown
Omni-Tract®	11183	FDA UDI	Class I	Active
Coral	10-11-7535	FDA UDI	Class II	Unknown
Omni-Tract®	3101R	FDA UDI	Class I	Active
Omni-Tract®	3882RP	FDA UDI	Class I	Active
Omni-Tract®	3610P	FDA UDI	Class I	Active
Omni-Tract®	4920P	FDA UDI	Class I	Active
Coral	18-26-9560	FDA UDI	Class II	Unknown
Coral	18-14-8580	FDA UDI	Class II	Unknown
Coral	18-12-9535	FDA UDI	Class II	Unknown
Omni-Tract®	4605	FDA UDI	Class I	Active
Omni-Tract®	3818RP	FDA UDI	Class I	Active
Coral	18-16-6565	FDA UDI	Class II	Unknown
Coral	18-22-9545	FDA UDI	Class II	Unknown
Coral	18-16-6560	FDA UDI	Class II	Unknown
Coral	18-26-5535	FDA UDI	Class II	Unknown
Sundt™	NL8505078	FDA UDI	Class II	Active
OmniSight™	OS7100	FDA UDI	Class II	Unknown
Omni-Tract®	11920P	FDA UDI	Class I	Active
Omni-Tract®	3376RP	FDA UDI	Class I	Active
Omni-Tract®	11383	FDA UDI	Class I	Active
Omni-Tract®	3978	FDA UDI	Class I	Active
Coral	10-10-8545	FDA UDI	Class II	Unknown
Omni-Tract®	11302RP	FDA UDI	Class I	Active
Omni-Tract®	3650P	FDA UDI	Class I	Active
Omni-Tract®	3883R	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Integra Lifesciences Corp. has 347 recall records spanning from December 16, 2002, to February 6, 2025, with statuses including open, classified, and terminated. The reasons cited involve labeling errors (e.g., incorrect model numbers, lot numbers, or pressure specifications), packaging and sterility concerns (e.g., improper seals, mislabeled kits, or damaged components), material inconsistencies affecting device performance (e.g., radiopacity or density variations), and distribution of non-conforming products (e.g., fractured pins or mismatched surgical instruments). Complaints from sales representatives and adverse event trends also prompted some recalls.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 6, 2025	Z-1295-2025	—	open, classified	Possibility for the obturator to break (separate).
Jan 10, 2025	Z-1168-2025	—	open, classified	Potential that the induction seal is not completely sealed to the device tube packaging.
Dec 16, 2024	Z-0977-2025	—	open, classified	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Dec 16, 2024	Z-0978-2025	—	open, classified	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Dec 16, 2024	Z-0979-2025	—	open, classified	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Sep 26, 2024	Z-0262-2025	—	open, classified	Out of specification endotoxin levels.
Sep 20, 2024	Z-0249-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0246-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0237-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0256-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0251-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0239-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0242-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0255-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0253-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0248-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0254-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0241-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0236-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0238-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0245-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0235-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0240-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0243-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0247-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0244-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0250-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 20, 2024	Z-0252-2025	—	open, classified	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Sep 13, 2024	Z-0054-2025	—	open, classified	There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Jul 9, 2024	Z-2507-2024	—	open, classified	Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
Jun 7, 2024	Z-2331-2024	—	open, classified	Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
May 29, 2024	Z-2167-2024	—	open, classified	Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
May 7, 2024	Z-2138-2024	—	open, classified	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
May 7, 2024	Z-2137-2024	—	open, classified	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
May 7, 2024	Z-2136-2024	—	open, classified	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
Apr 17, 2024	Z-1873-2024	—	open, classified	Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Jan 19, 2024	Z-1203-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1201-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1199-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1193-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1196-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1197-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1195-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1200-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1202-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1194-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024	Z-1198-2024	—	open, classified	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Oct 19, 2023	Z-0496-2024	—	open, classified	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023	Z-0495-2024	—	open, classified	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023	Z-0492-2024	—	open, classified	Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023	Z-0493-2024	—	open, classified	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023	Z-0498-2024	—	open, classified	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023	Z-0494-2024	—	open, classified	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023	Z-0499-2024	—	open, classified	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023	Z-0491-2024	—	open, classified	Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023	Z-0497-2024	—	open, classified	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 5, 2023	Z-0548-2024	—	open, classified	Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.
Apr 11, 2023	Z-1614-2023	—	open, classified	Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.
Dec 2, 2022	Z-0909-2023	—	open, classified	Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
Jun 22, 2022	Z-1395-2022	—	open, classified	Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.
Feb 28, 2022	Z-0906-2022	—	open, classified	Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
Jan 21, 2022	Z-0818-2022	—	terminated	Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
Jan 21, 2022	Z-0817-2022	—	terminated	Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
Jun 1, 2021	Z-2224-2021	—	terminated	Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Mar 17, 2021	Z-1354-2021	—	terminated	Incorrect labeling, Catheter did not have the required holes and markings
Dec 14, 2020	Z-0725-2021	—	terminated	Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Dec 14, 2020	Z-0724-2021	—	terminated	Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Nov 11, 2020	Z-0548-2021	—	terminated	Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
Aug 4, 2020	Z-2954-2020	—	terminated	lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Aug 4, 2020	Z-2953-2020	—	terminated	lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Aug 4, 2020	Z-2955-2020	—	terminated	lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Feb 7, 2020	Z-1470-2020	—	terminated	Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
Oct 21, 2019	Z-0643-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0613-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0625-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0648-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0622-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0618-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0651-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0637-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0616-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0641-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0635-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0640-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0645-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0630-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0650-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0634-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0620-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0647-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0619-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0629-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0654-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0633-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0631-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0627-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0636-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0639-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0621-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Oct 21, 2019	Z-0644-2020	—	terminated	The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.