Identity
- Trade Name
- Hermetic™ Plus FDA UDI
- Generic Name
- Ventricular cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- Hermetic™ Plus External CSF Drainage System with Anti-Reflux Valve and Needleless Injection Site FDA UDI
- Model / Reference
- SP0211 FDA UDI
- Description
- Hermetic™ Plus External CSF Drainage System with Anti-Reflux Valve and Needleless Injection Site FDA UDI
Identifiers
- Catalog Number
- SP0211 FDA UDI
- Primary DI / UDI-DI
- 10381780072034 FDA UDI
- 510(k) Number
- K030289 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventricular 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™ Plus by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventricular cerebrospinal fluid drainage catheterization kit.
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- Integra — Integra Pain Management
- Exacta™ — Medtronic PS Medical · Class II
- Becker — Medtronic PS Medical · Class II
- Integra — Integra Pain Management
Cleared under the same submission
K030289 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 4d2b1266-5b67-48fe-84f5-adc7928c8ce0 36 fields · synced May 29, 2026