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Integra Lifesciences Corp.

US

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 66 of 76
DeviceModel / ReferenceRegistriesClassStatus
Integra® Padgett® Dermatomes 353971525
FDA UDI
Class IActive
Omni-Tract® 4967P
FDA UDI
Class IActive
Stainless Steel 25-12-6595
FDA UDI
Class IIUnknown
Stainless Steel 25-34-9590
FDA UDI
Class IIUnknown
Mayfield® 417A1004
FDA UDI
Class IIActive
Coral 10-10-5565
FDA UDI
Class IIUnknown
Budde® A1040P
FDA UDI
Class IIActive
Integra® Padgett® Dermatomes 35396105
FDA UDI
Class IActive
Integra® 438A1193A
FDA UDI
Class IIActive
Integra® NL8501412
FDA UDI
Class IIActive
Stainless Steel 25-10-4025
FDA UDI
Class IIUnknown
Coral 18-14-6595
FDA UDI
Class IIUnknown
Coral 18-22-6540
FDA UDI
Class IIUnknown
OmniSight™ OS4003
FDA UDI
Class IIUnknown
Hermetic™ SP0204
FDA UDI
Class IIActive
Coral 18-12-9585
FDA UDI
Class IIUnknown
Coral 18-24-9590
FDA UDI
Class IIUnknown
Integra® 438A1083B
FDA UDI
Class IIActive
Stainless Steel 25-32-8590
FDA UDI
Class IIUnknown
Omni-Tract® 11502R
FDA UDI
Class IActive
NeuraGen® PNG320
FDA UDI
Class IIActive
Coral 10-10-5545
FDA UDI
Class IIUnknown
Integra® 438A1151D
FDA UDI
Class IIActive
Mayfield® A1117
FDA UDI
Class IIActive
Coral 18-24-4555
FDA UDI
Class IIUnknown
Integra® Padgett® DP0006
FDA UDI
Class IActive
Omni-Tract® 3053R
FDA UDI
Class IActive
Integra® NL8501228
FDA UDI
Class IIActive
Coral 18-12-4520
FDA UDI
Class IIUnknown
Stainless Steel 25-14-6555
FDA UDI
Class IIUnknown
Trel X-Press 100 XPRES105
FDA UDI
Class IIActive
Coral 10-11-8570
FDA UDI
Class IIUnknown
Omni-Tract® 3098
FDA UDI
Class IActive
Tew? 438A1155A
FDA UDI
Class IIActive
Mayfield® 41A1226
FDA UDI
Class IIActive
DuraGen® Plus DP5013
FDA UDI
Class IIActive
Stainless Steel 25-12-4060
FDA UDI
Class IIUnknown
Coral 18-12-7560
FDA UDI
Class IIUnknown
Stainless Steel 25-15-8560
FDA UDI
Class IIUnknown
Coral 10-12-5555
FDA UDI
Class IIUnknown
Stainless Steel 25-35-9560
FDA UDI
Class IIUnknown
Tew? 438A1155C
FDA UDI
Class IIActive
Coral 18-12-7570
FDA UDI
Class IIUnknown
Omni-Tract® 11384P
FDA UDI
Class IActive
Crw® CRWPMDB30
FDA UDI
Class IIUnknown
Omni-Tract® 11921
FDA UDI
Class IActive
Stainless Steel 25-34-8560
FDA UDI
Class IIUnknown
Coral 10-12-6540
FDA UDI
Class IIUnknown
Omni-Tract® 3217
FDA UDI
Class IActive
Omni-Tract® 3259RP
FDA UDI
Class IActive

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.

DateRecall No.ClassStatusReason
Feb 6, 2025Z-1295-2025—open, classified

Possibility for the obturator to break (separate).

Jan 10, 2025Z-1168-2025—open, classified

Potential that the induction seal is not completely sealed to the device tube packaging.

Dec 16, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-0262-2025—open, classified

Out of specification endotoxin levels.

Sep 20, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-0054-2025—open, classified

There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

Jul 9, 2024Z-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, 2024Z-2331-2024—open, classified

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

May 29, 2024Z-2167-2024—open, classified

Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

May 7, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2024Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2023Z-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, 2022Z-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, 2022Z-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, 2022Z-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, 2022Z-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, 2022Z-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, 2021Z-2224-2021—terminated

Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier

Mar 17, 2021Z-1354-2021—terminated

Incorrect labeling, Catheter did not have the required holes and markings

Dec 14, 2020Z-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, 2020Z-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, 2020Z-0548-2021—terminated

Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram

Aug 4, 2020Z-2954-2020—terminated

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

Aug 4, 2020Z-2953-2020—terminated

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

Aug 4, 2020Z-2955-2020—terminated

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

Feb 7, 2020Z-1470-2020—terminated

Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.

Oct 21, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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, 2019Z-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.