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Device Explorer · FDA GUDID · GMDN 48155

Dura mater biomatrix implant

A bioabsorbable device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of the

US‑registered devices108in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Collagen Matrix, Inc.4643%
Integra Lifesciences Corporation2624%
Cook Biotech Incorporated1615%
Aesculap Ag1110%
Natus Medical Incorporated87%
Cerenovus, Inc.11%

Top labelers

CompanyDevicesShare
Collagen Matrix, Inc.4643%
Integra Lifesciences Corporation2624%
Cook Biotech Incorporated1615%
Aesculap Ag1110%
Natus Medical Incorporated87%
Cerenovus, Inc.11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LYOPLANT ONLAYLYOPLANTBiodesignKBIO® DuraDuraMend SuturableDuraMend-Onlay™DuraMend™DuraMend-Onlay™ PlusDuraMatrix-Onlay PlusDuraMatrix SuturableDuraMatrix OnlayDuraMatrixDURASISDURAFORMDuraGen® PlusDuraGen® Secure

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

FDA product codes

CodeNameDevices
GXQDura Substitute62
GXQDURA SUBSTITUTE61
FTMMesh, Surgical4

GMDN & GCC registration

  • GMDN code 48155 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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 (Inch) · 49Width (Inch) · 49Width (Millimeter) · 6Length (Millimeter) · 6Width (Centimeter) · 6Length (Centimeter) · 6

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

How many dura mater biomatrix implant products are registered in the US?

108 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dura mater biomatrix implant", from 6 companies. The largest labeler is Collagen Matrix, Inc. with 43% of records.

Which FDA product codes apply?

GXQ (Dura Substitute), GXQ (DURA SUBSTITUTE), 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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