Identity
- Trade Name
- Hermetic™ FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, long-term FDA UDI
- Device Name
- Hermetic™ Large-Style Ventricular Catheter Set FDA UDI
- Model / Reference
- INS4500 FDA UDI
- Description
- Hermetic™ Large-Style Ventricular Catheter Set FDA UDI
Identifiers
- Catalog Number
- INS4500 FDA UDI
- Primary DI / UDI-DI
- 10381780071075 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Intracerebral infusion/drainage catheter, long-term 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
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: Intracerebral infusion/drainage catheter, long-term
Hermetic™ by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral infusion/drainage catheter, long-term.
- BioGlide® — Medtronic PS Medical · Class II
- Phoenix Neuro — Sophysa SA · Class II
- Innervision, BioGlide® — Medtronic PS Medical · Class II
- Natus® — Natus Medical Incorporated · Class II
- CODMAN® BACTISEAL® — Integra LifeSciences Production Corporation · Class II
- Phoenix Neuro — Sophysa SA · Class II
- CODMAN® ACCU-FLO® — Integra LifeSciences Production Corporation · Class II
- Innervision — Medtronic PS Medical · Class II
Cleared under the same submission
K820247 also covers:
K970658 also covers:
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Hermetic™ External Drainage Lumbar Catheter — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- TraumaCath™ — Integra Lifesciences Corp.
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 9bb61e05-7104-49ee-9345-08a50bdbc531 37 fields · synced May 30, 2026