Identity
- Trade Name
- NervAlign Nerve Cuff FDA UDI
- Generic Name
- Nerve guide, animal-derived FDA UDI
- Device Name
- An absorbable collagen membrane implant that provides non-constricting protection for peripheral nerves. It is designed to be an interface between the nerve and the surrounding tissue and used for the repair of peripheral nerves in which there is no gap or where a gap closure is achieved by flexion of the extremity. FDA UDI
- Model / Reference
- NA-NC3040 FDA UDI
- Description
- An absorbable collagen membrane implant that provides non-constricting protection for peripheral nerves. It is designed to be an interface between the nerve and the surrounding tissue and used for the repair of peripheral nerves in which there is no gap or where a gap closure is achieved by flexion of the extremity. FDA UDI
Identifiers
- Catalog Number
- NA-NC3040 FDA UDI
- Primary DI / UDI-DI
- 09369998231904 FDA UDI
- 510(k) Number
- K202234 FDA UDI
- FDA Product Code
- JXI FDA UDI
- GMDN Term
- Nerve guide, animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5275 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
No
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: Nerve guide, animal-derived
NervAlign Nerve Cuff by Renerve, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nerve guide, animal-derived.
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- AxoGuard — COOK BIOTECH INCORPORATED · Class II
- AxoGuard Nerve Cap — AxoGen Corporation · Class II
- ConformaWrap — Biocircuit Technologies, Inc. · Class II
Cleared under the same submission
K202234 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 |
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Manufacturer
- Manufacturer
- Renerve, Ltd.
Sources (1)
- FDA UDI 7a7079e7-9d3e-4fda-9fe4-896406f11fab 36 fields · synced Jun 8, 2026