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Device Explorer · FDA GUDID · GMDN 43233

Nerve guide, animal-derived

An implantable tubular device made exclusively of animal-derived bioabsorbable material(s) [e.g., porcine-derived collagen matrix, chitosan] intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the prox

US‑registered devices147in commercial distribution
Companies10labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Cook Biotech Incorporated4631%
Collagen Matrix, Inc.3725%
Integra Lifesciences Corporation3524%
Axogen Corporation117%
Orthocell Limited43%
Klisbio Srl43%
Checkpoint Surgical, Inc.32%
Renerve Limited32%

Top labelers

CompanyDevicesShare
Cook Biotech Incorporated4631%
Collagen Matrix, Inc.3725%
Integra Lifesciences Corporation3524%
Axogen Corporation117%
Orthocell Limited43%
Klisbio Srl43%
Checkpoint Surgical, Inc.32%
Renerve Limited32%
Biocircuit Technologies, Inc.21%
Monarch Bioimplants Gmbh21%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Axoguard HA+ Nerve ProtectorAxoGuard Nerve CapAxoGuard NerveCapAxoGuardCHECKPOINT AxioCorArthrex Nerve WrapArthrex Nerve ConduitTenoWrapNeuroMendNeuroFlexNeuroMatrixProVeil Hydrogel MembraneCheckpoint NeuroShield Chitosan MembraneNeuraGen® 3DNeuraGen®NeuraWrap®

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
JXICUFF, NERVE81
JXICuff, Nerve71
FTMMesh, Surgical2

GMDN & GCC registration

  • GMDN code 43233 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 40Lumen/Inner Diameter (Millimeter) · 18Outer Diameter (Millimeter) · 14Width (Millimeter) · 6Length (Millimeter) · 6

Use these as the dimensions to specify in a tender line.

How many nerve guide, animal-derived products are registered in the US?

147 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nerve guide, animal-derived", from 10 companies. The largest labeler is Cook Biotech Incorporated with 31% of records.

Which FDA product codes apply?

JXI (CUFF, NERVE), JXI (Cuff, Nerve), FTM (Mesh, Surgical)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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