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Device Explorer · FDA GUDID · GMDN 46580

Extra-gynaecological surgical mesh, metal

A non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or

US‑registered devices225in commercial distribution
Companies11labelers on GUDID
Single‑use100%of device records
Sterile13%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medtronic Sofamor Danek, Inc.13259%
Medicon Eg. Chirurgiemechaniker-Genossenschaft3516%
Dentis Co. ,Ltd125%
Ace Surgical Supply Co., Inc.115%
Synthes Gmbh115%
Smith & Nephew, Inc.94%
Howmedica Osteonics Corp.84%
Zimvie Us Corp Llc21%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.13259%
Medicon Eg. Chirurgiemechaniker-Genossenschaft3516%
Dentis Co. ,Ltd125%
Ace Surgical Supply Co., Inc.115%
Synthes Gmbh115%
Smith & Nephew, Inc.94%
Howmedica Osteonics Corp.84%
Zimvie Us Corp Llc21%
Osteogenics Biomedical Inc21%
Bioplate, Inc.21%
Osstem Implant Co., Ltd.10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

X-ChangeMediconContourOSSEOGUARD®Cytoplast™ Osteo-Mesh TM-300Pyramesh® Implant SystemPYRAMESH® C Titanium MeshPYRAMESH® Implant SystemACEARTISAN™ SPACE MAINTENANCE SYSTEMMatrixNEUROBioplate®MU Click Bridge Caps-Clean Sole Abutment Healing Capi-Clean Excellent Solid Abutment Healig Capi-Clean Solid Abutment Healing Cap

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

FDA product codes

CodeNameDevices
EZXMesh, surgical, metal130
MQPSpinal vertebral body replacement device128
JEYPLATE, BONE41
JDJMesh, surgical, acetabular, hip, prosthesis17
NHAAbutment, Implant, Dental, Endosseous15
GWOPlate, cranioplasty, preformed, alterable12

GMDN & GCC registration

  • GMDN code 46580 · implantable
  • Single‑use 100% · sterile 13% · 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 (Millimeter) · 38Outer Diameter (Millimeter) · 23Width (Millimeter) · 13

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

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

225 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Extra-gynaecological surgical mesh, metal", from 11 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 59% of records.

Which FDA product codes apply?

EZX (Mesh, surgical, metal), MQP (Spinal vertebral body replacement device), JEY (PLATE, BONE), JDJ (Mesh, surgical, acetabular, hip, prosthesis)

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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