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Nerve Tape®

FDA UDI

Class II (US FDA UDI)

by Biocircuit Technologies, Inc.

Identity

Trade Name
Nerve Tape® FDA UDI
Generic Name
Nerve guide, metal/animal-derived FDA UDI
Device Name
Nerve Tape® is a surgical implant designed to align and connect peripheral nerves. Nerve Tape® is designed to be an interface between the nerve and the surrounding tissue. Nerve Tape® is comprised of an extracellular matrix (ECM), which is fully remodeled during the healing process, and Nitinol microhooks, which bind coapted nerve ends together. When hydrated, Nerve Tape® is easy to handle, soft, pliable, nonfriable, and porous. Nerve Tape® has sufficient mechanical strength to hold the ends of the nerve together. Nerve Tape® is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. FDA UDI
Model / Reference
NT30-14 FDA UDI
Description
Nerve Tape® is a surgical implant designed to align and connect peripheral nerves. Nerve Tape® is designed to be an interface between the nerve and the surrounding tissue. Nerve Tape® is comprised of an extracellular matrix (ECM), which is fully remodeled during the healing process, and Nitinol microhooks, which bind coapted nerve ends together. When hydrated, Nerve Tape® is easy to handle, soft, pliable, nonfriable, and porous. Nerve Tape® has sufficient mechanical strength to hold the ends of the nerve together. Nerve Tape® is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. FDA UDI

Identifiers

Catalog Number
NT30-14 FDA UDI
Primary DI / UDI-DI
G517NT30140 FDA UDI
510(k) Number
K233533 FDA UDI
FDA Product Code
JXI FDA UDI
GMDN Term
Nerve guide, metal/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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 3.0 Millimeter FDA UDI

Category: Nerve guide, metal/animal-derived

Nerve Tape® by Biocircuit Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve guide, metal/animal-derived.

Cleared under the same submission

K233533 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocircuit Technologies, Inc.

Sources (1)

  • FDA UDI 09ebbbc9-5e95-42e1-91ae-dd30afb3e34b 37 fields · synced Jun 8, 2026