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Device Explorer · FDA GUDID · GMDN 44756

Extra-gynaecological surgical mesh, composite-polymer

A partially-bioabsorbable, implantable material (e.g., flat sheet) made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended for extra-gynaecological, n

US‑registered devices255in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription96%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Sofradim Production11043%
Johnson & Johnson International Inc.5120%
Davol Inc.4417%
W. L. Gore & Associates, Inc.166%
Cousin Biotech114%
Insightra Medical, Inc.94%
Pfm Medical Titanium Gmbh62%
Anika Therapeutics, Inc.42%

Top labelers

CompanyDevicesShare
Sofradim Production11043%
Johnson & Johnson International Inc.5120%
Davol Inc.4417%
W. L. Gore & Associates, Inc.166%
Cousin Biotech114%
Insightra Medical, Inc.94%
Pfm Medical Titanium Gmbh62%
Anika Therapeutics, Inc.42%
Covidien Lp42%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ti-MESH4DDOME ®4DDOME®BIOMESH®CA.B.S.'Air®Biomesh® CA.B.S.’Air® CompositeFreedom - Ventral Hernia Repair SystemFreedom - ProFlor Inguinal Hernia ImplantIntegrity ImplantVENTRALIGHTSEPRAMESHVENTRIOVENTRALEXGORE SYNECOR Preperitoneal BiomaterialGORE SYNECOR BiomaterialProGripParietene DS

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

FDA product codes

CodeNameDevices
FTLMesh, surgical, polymeric326
FTLMesh, Surgical, Polymeric51
GCJLaparoscope, general & plastic surgery17
OXAMesh, surgical, non-absorbable, thoracic, chest wall reconst17
OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects11
ORQMesh, surgical, deployer11

GMDN & GCC registration

  • GMDN code 44756 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 96% · 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) · 137Width (Centimeter) · 137Outer Diameter (Centimeter) · 57Outer Diameter (Millimeter) · 19Length (Inch) · 11Height (Millimeter) · 6

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

How many extra-gynaecological surgical mesh, composite-polymer products are registered in the US?

255 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Extra-gynaecological surgical mesh, composite-polymer", from 9 companies. The largest labeler is Sofradim Production with 43% of records.

Which FDA product codes apply?

FTL (Mesh, surgical, polymeric), FTL (Mesh, Surgical, Polymeric), GCJ (Laparoscope, general & plastic surgery), OXA (Mesh, surgical, non-absorbable, thoracic, chest wall reconst)

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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