Identity
- Trade Name
- NeuroMend® EUDAMEDNeuroMend FDA UDI
- Generic Name
- Nerve guide, animal-derived FDA UDI
- Device Name
- Collagen Nerve Wrap EUDAMEDCollagen Nerve Wrap 4mm (inner diameter) x 5cm (length) FDA UDICollagen Nerve Wrap 6mm (inner diameter) x 2.5cm (length) FDA UDI
- Model / Reference
- CNW6025 EUDAMEDFDA UDICNW4050 FDA UDI
- Description
- Collagen Nerve Wrap 4mm (inner diameter) x 5cm (length) FDA UDICollagen Nerve Wrap 6mm (inner diameter) x 2.5cm (length) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813954020136 EUDAMEDFDA UDI00813954020150 FDA UDI
- Basic UDI-DI
- B-00813954020136 EUDAMED
- 510(k) Number
- K060952 FDA UDI
- FDA Product Code
- JXI FDA UDI
- EMDN Code
- N0199 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER EUDAMED
- GMDN Term
- Nerve guide, animal-derived FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5275 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Length — 5 Centimeter FDA UDILumen/Inner Diameter — 4 Millimeter FDA UDILength — 2.5 Centimeter FDA UDILumen/Inner Diameter — 6 Millimeter FDA UDI
Category: Nerve guide, animal-derived
NeuroMend by Collagen Matrix, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nerve guide, animal-derived.
- AxoGuard — COOK BIOTECH INCORPORATED · Class II
- NeuraGen® — Integra Lifesciences Corp. · Class II
- AxoGuard — COOK BIOTECH INCORPORATED · Class II
- AxoGuard — COOK BIOTECH INCORPORATED · Class II
- AxoGuard Nerve Cap — AxoGen Corporation · Class II
- ConformaWrap — Biocircuit Technologies, Inc. · Class II
- Checkpoint Nerve Repair Kit — Checkpoint Surgical, Inc.
- NeuraGen® — Integra Lifesciences Corp. · Class II
Cleared under the same submission
K060952 also covers:
- Arthrex Nerve Wrap — COLLAGEN MATRIX, INC.
- Arthrex Nerve Wrap — COLLAGEN MATRIX, INC.
- Arthrex Nerve Wrap — COLLAGEN MATRIX, INC.
- Arthrex Nerve Wrap — COLLAGEN MATRIX, INC.
- Arthrex Nerve Wrap — COLLAGEN MATRIX, INC.
- Arthrex Nerve Wrap — COLLAGEN MATRIX, INC.
- NeuroMend — COLLAGEN MATRIX, INC.
- NeuroMend — COLLAGEN MATRIX, INC.
- NeuroMend — COLLAGEN MATRIX, INC.
- NeuroMend — COLLAGEN MATRIX, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Collagen Matrix, Inc.
Sources (3)
- FDA UDI 7d1284b3-58cd-4a88-9b07-15aab984b432 35 fields · synced Jul 8, 2026
- FDA UDI e7811238-11f9-4ec1-a165-ec89284fe956 35 fields · synced May 30, 2026
- EUDAMED 6f278f55-062b-4e59-b553-a5a1fa296c73 61 fields · synced Jul 8, 2026