ConformaWrap

FDA UDI

Class II (US FDA UDI)

by Biocircuit Technologies, Inc.

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: CW4080 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: CW4080 FDA UDI
Primary DI / UDI-DI: G517CW4080 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

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 80 Millimeter FDA UDI
Width — 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.

AxoGuard — COOK BIOTECH INCORPORATED · Class II
NeuraGen® — Integra Lifesciences Corp. · Class II
AxoGuard — COOK BIOTECH INCORPORATED · Class II
NeuroFlex — COLLAGEN MATRIX, INC. · Class II
NeuroMatrix — COLLAGEN MATRIX, INC. · Class II
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 6b29af3d-992f-4b62-a2b9-43000e9e816d 36 fields · synced May 30, 2026