Consulting Wallah › Device Explorer › Other devices › Nerve guide, synthetic polymer, bioabsorbable
Device Explorer · FDA GUDID · GMDN 44814

Nerve guide, synthetic polymer, bioabsorbable

An implantable device intended to be used 1) to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve ends, 2) to encase a nerve for protection to aid in repair [e.g., to prevent ingrowth of scar

US‑registered devices56in commercial distribution
Companies8labelers on GUDID
Single‑use96%of device records
Sterile96%labelled sterile
Prescription77%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Polyganics Innovations B.V.1934%
Tissium1629%
Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.1018%
Alafair Biosciences, Inc.47%
Tulavi Therapeutics, Inc.24%
Synovis Micro Companies Alliance, Inc24%
Accurate Surgical & Scientific Instruments Corporation24%
Mochida Pharmaceutical Co., Ltd.12%

Top labelers

CompanyDevicesShare
Polyganics Innovations B.V.1934%
Tissium1629%
Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.1018%
Alafair Biosciences, Inc.47%
Tulavi Therapeutics, Inc.24%
Synovis Micro Companies Alliance, Inc24%
Accurate Surgical & Scientific Instruments Corporation24%
Mochida Pharmaceutical Co., Ltd.12%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Rebuilder Nerve Guidance ConduitReFeelCOAPTIUM® Connectallay™ Nerve Cap - Large Nerve Setallay™ Nerve Cap - Small Nerve SetNeurotubeASSIVersaCoat Flowable HydrogelVersaWrapNeurolac TWNEUROCAPNeurolac

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

FDA product codes

CodeNameDevices
JXICuff, Nerve34
SFDIn Situ Polymerizing Peripheral Nerve Repair Device16
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of T4
SBGIn Situ Polymerizing Peripheral Nerve Cap2
JXICUFF, NERVE2
GDIDissector, Surgical, General & Plastic Surgery2

GMDN & GCC registration

  • GMDN code 44814 · implantable
  • Single‑use 96% · sterile 96% · Rx‑only 77% · 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 (Millimeter) · 18Outer Diameter (Millimeter) · 16Lumen/Inner Diameter (Millimeter) · 11Total Volume (Milliliter) · 3Length (Inch) · 1Width (Inch) · 1

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

How many nerve guide, synthetic polymer, bioabsorbable products are registered in the US?

56 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nerve guide, synthetic polymer, bioabsorbable", from 8 companies. The largest labeler is Polyganics Innovations B.V. with 34% of records.

Which FDA product codes apply?

JXI (Cuff, Nerve), SFD (In Situ Polymerizing Peripheral Nerve Repair Device), OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of T), SBG (In Situ Polymerizing Peripheral Nerve Cap)

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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