Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Ventriculoperitoneal shunt FDA UDI
- Device Name
- Integra® Essential Shunt Kit Flat Bottom Design FDA UDI
- Model / Reference
- NL8504121 FDA UDI
- Description
- Integra® Essential Shunt Kit Flat Bottom Design FDA UDI
Identifiers
- Catalog Number
- NL8504121 FDA UDI
- Primary DI / UDI-DI
- 10381780356158 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventriculoperitoneal shunt 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
MR Conditional FDA UDI
Category: Ventriculoperitoneal shunt
Integra® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventriculoperitoneal shunt.
- StrataMR II — Medtronic PS Medical · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- Strata®, BioGlide® — Medtronic PS Medical · Class II
- Delta®, BioGlide® — Medtronic PS Medical · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- Strata® — Medtronic PS Medical · Class II
- Strata™ — Medtronic PS Medical · Class II
Cleared under the same submission
K153041 also covers:
- Integra Essential Shunt Kit — Integra Lifesciences Corp.
- Integra Essential Shunt Kit — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Novus™ — Integra Lifesciences Corp.
- Novus™ — Integra Lifesciences Corp.
- Novus™ — 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 a778e2eb-2715-4c2d-8afc-361ef69e226b 37 fields · synced May 30, 2026