Identity
- Trade Name
- Arthrex Nerve Conduit FDA UDI
- Generic Name
- Nerve guide, animal-derived FDA UDI
- Device Name
- Flexible Collagen Nerve Tube FDA UDI
- Model / Reference
- ABS-3025C FDA UDI
- Description
- Flexible Collagen Nerve Tube FDA UDI
Identifiers
- Catalog Number
- ABS-3025C FDA UDI
- Primary DI / UDI-DI
- 00813954027296 FDA UDI
- 510(k) Number
- K131541 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
Arthrex Nerve Conduit by Collagen Matrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nerve guide, animal-derived.
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- Checkpoint Nerve Repair Kit — Checkpoint Surgical, Inc.
- NeuraGen® — Integra Lifesciences Corp. · Class II
Cleared under the same submission
K131541 also covers:
- Arthrex Nerve Conduit — COLLAGEN MATRIX, INC.
- Arthrex Nerve Conduit — COLLAGEN MATRIX, INC.
- Arthrex Nerve Conduit — COLLAGEN MATRIX, INC.
- Arthrex Nerve Conduit — COLLAGEN MATRIX, INC.
- Arthrex Nerve Conduit — COLLAGEN MATRIX, INC.
- NeuroFlex — COLLAGEN MATRIX, INC.
- NeuroFlex — COLLAGEN MATRIX, INC.
- NeuroFlex — COLLAGEN MATRIX, INC.
- NeuroFlex — COLLAGEN MATRIX, INC.
- NeuroFlex — COLLAGEN MATRIX, INC.
- NeuroFlex — COLLAGEN MATRIX, INC.
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
- Collagen Matrix, Inc.
Sources (1)
- FDA UDI ad8d4009-f8e8-4be8-9c5a-d33801cc1657 38 fields · synced Jun 8, 2026