Identity
- Trade Name
- Hermetic™ FDA UDI
- Generic Name
- Lumbar cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- Hermetic™ External CSF Drainage System with Pressure Tubing FDA UDI
- Model / Reference
- INS8601 FDA UDI
- Description
- Hermetic™ External CSF Drainage System with Pressure Tubing FDA UDI
Identifiers
- Catalog Number
- INS8601 FDA UDI
- Primary DI / UDI-DI
- 10381780072164 FDA UDI
- 510(k) Number
- K972994 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Lumbar cerebrospinal fluid drainage catheterization kit 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Lumbar cerebrospinal fluid drainage catheterization kitVentricular cerebrospinal fluid drainage catheterization kit
Hermetic™ by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ventricular cerebrospinal fluid drainage catheterization kit.
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Cleared under the same submission
K972994 also covers:
- External CSF Drainage System Collection Bag — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ II — Integra Lifesciences Corp.
- Hermetic™ II — Integra Lifesciences Corp.
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 0dbf252d-b343-4f58-8fab-87de045501aa 37 fields · synced May 30, 2026