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Device Explorer · FDA GUDID · GMDN 60300

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polycarbonate (PC), carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, p

US‑registered devices406in commercial distribution
Companies13labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription91%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Davol Inc.9323%
Sofradim Production7418%
Herniamesh Srl5413%
Aspide Medical4712%
Feg Textiltechnik Forschungs- Und Entwicklungsges. Mbh4511%
W. L. Gore & Associates, Inc.266%
Bg Medical, Llc256%
Ethicon, Llc143%

Top labelers

CompanyDevicesShare
Davol Inc.9323%
Sofradim Production7418%
Herniamesh Srl5413%
Aspide Medical4712%
Feg Textiltechnik Forschungs- Und Entwicklungsges. Mbh4511%
W. L. Gore & Associates, Inc.266%
Bg Medical, Llc256%
Ethicon, Llc143%
Healthium Medtech Limited102%
Ethicon Inc.72%
Medlinx Acacia Pte. Ltd.51%
Pfm Medical Titanium Gmbh41%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DynaMeshTiMESHSurgimesh WNSURGIMESH®XBSURGIMESH®WNSURGIMESH®EASYPLUG®SurgiMesh3DMAXONFLEXCOMPOSIXPerFixBARDKUGELVENTRALEXVENTRIOKugel

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, polymeric306
FTLMesh, Surgical, Polymeric277
OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects14
OQLMesh, surgical, deployment balloon6
GCJLaparoscope, general & plastic surgery6
QWUProsthesis, Eyelid Spacer/Graft, Polymer2

GMDN & GCC registration

  • GMDN code 60300 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 91% · 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

Width (Centimeter) · 236Length (Centimeter) · 226Height (Millimeter) · 66Height (Centimeter) · 32Outer Diameter (Centimeter) · 31Length (Inch) · 16

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

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

406 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable", from 13 companies. The largest labeler is Davol Inc. with 23% of records.

Which FDA product codes apply?

FTL (Mesh, surgical, polymeric), FTL (Mesh, Surgical, Polymeric), OXJ (Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects), OQL (Mesh, surgical, deployment balloon)

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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