Identity
- Trade Name
- ConformaWrap FDA UDI
- Generic Name
- Nerve guide, animal-derived FDA UDI
- Device Name
- ConformaWrap is a surgical implant designed to protect a damaged peripheral nerve, serving as a non-constricting interface between the nerve and the surrounding tissue. ConformaWrap is composed of an extracellular matrix (ECM), which is fully remodeled during the healing process. When hydrated, ConformaWrap is easy to handle, soft, pliable, nonfriable, and porous. ConformaWrap is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. FDA UDI
- Model / Reference
- CW2040 FDA UDI
- Description
- ConformaWrap is a surgical implant designed to protect a damaged peripheral nerve, serving as a non-constricting interface between the nerve and the surrounding tissue. ConformaWrap is composed of an extracellular matrix (ECM), which is fully remodeled during the healing process. When hydrated, ConformaWrap is easy to handle, soft, pliable, nonfriable, and porous. ConformaWrap is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. FDA UDI
Identifiers
- Catalog Number
- CW2040 FDA UDI
- Primary DI / UDI-DI
- G517CW2040 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
No
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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Width — 20 Millimeter FDA UDILength — 40 Millimeter FDA UDI
Category: Nerve guide, animal-derived
ConformaWrap by Biocircuit Technologies, 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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- AxoGuard — COOK BIOTECH INCORPORATED · Class II
- AxoGuard Nerve Cap — AxoGen Corporation · Class II
- Checkpoint Nerve Repair Kit — Checkpoint Surgical, 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
- Biocircuit Technologies, Inc.
Sources (1)
- FDA UDI 513345bc-19c8-47be-a58a-9591dddd14e9 36 fields · synced Jun 6, 2026