Identity
- Trade Name
- Integra NeuroSciences Connector FDA UDI
- Generic Name
- Cerebrospinal fluid shunt connector FDA UDI
- Device Name
- The lumbar-peritoneal shunt connector is manufactured from stainless steel material. A reduced diameter tip facilitates insertion of a connector into a catheter tube. A single groove is considered standard and is located near each connector end to accommodate a ligature. This type of end is inserted into flushing devices and all catheters that are not spring-reinforced. A threaded (or multi-grooved) end is designed for insertion into spring-reinforced catheters, ventricular or peritoneal models. FDA UDI
- Model / Reference
- NL75121S06 FDA UDI
- Description
- The lumbar-peritoneal shunt connector is manufactured from stainless steel material. A reduced diameter tip facilitates insertion of a connector into a catheter tube. A single groove is considered standard and is located near each connector end to accommodate a ligature. This type of end is inserted into flushing devices and all catheters that are not spring-reinforced. A threaded (or multi-grooved) end is designed for insertion into spring-reinforced catheters, ventricular or peritoneal models. FDA UDI
Identifiers
- Catalog Number
- NL75121S06 FDA UDI
- Primary DI / UDI-DI
- 10381780071211 FDA UDI
- 510(k) Number
- K811288 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Cerebrospinal fluid shunt connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cerebrospinal fluid shunt connector
Integra NeuroSciences Connector by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cerebrospinal fluid shunt connector.
- Phoenix Neuro — Sophysa SA · Class II
- AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
- Natus® — Natus Medical Incorporated · Class II
- AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
- AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
- Natus® — Natus Medical Incorporated · Class II
- AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
- Phoenix Neuro — Sophysa SA · Class II
Cleared under the same submission
K811288 also covers:
- Integra Spetzler™ Lumbar Peritoneal Shunt System — Integra Lifesciences Corp.
- Integra Spetzler™ Lumbar Peritoneal Shunt System — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Natus® — Natus Medical Incorporated
- Natus® — Natus Medical Incorporated
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI cb34707f-78d9-4acb-8cfc-25081c351763 38 fields · synced May 30, 2026