Identity
- Trade Name
- Integra LPV II Valve Shunt Kit FDA UDI
- Generic Name
- Ventriculoperitoneal shunt FDA UDI
- Device Name
- STANDARD LPV II SHUNT KIT, MED. The Integra LPV II Valve Shunt Kits are designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. The kit contains a LPV II valve, standard, a Pudenz Ventricular Catheter and an integral, open-ended kink resistant catheter attached to the outlet of the valve. The kit is available in a medium pressure range. All valves and catheters contain barium sulfate for x-ray detectability. FDA UDI
- Model / Reference
- NL8509850 FDA UDI
- Description
- STANDARD LPV II SHUNT KIT, MED. The Integra LPV II Valve Shunt Kits are designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. The kit contains a LPV II valve, standard, a Pudenz Ventricular Catheter and an integral, open-ended kink resistant catheter attached to the outlet of the valve. The kit is available in a medium pressure range. All valves and catheters contain barium sulfate for x-ray detectability. FDA UDI
Identifiers
- Catalog Number
- NL8509850 FDA UDI
- Primary DI / UDI-DI
- 10381780072485 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
Category: Ventriculoperitoneal shunt
Integra LPV II Valve Shunt Kit by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
- Integra® — 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 3a413274-c676-43a5-9530-768aadd7da07 37 fields · synced May 30, 2026