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Device Explorer · FDA GUDID · GMDN 47986

Female stress urinary incontinence surgical mesh-sling, synthetic polymer

A woven/knitted or porous strip of material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of

US‑registered devices56in commercial distribution
Companies8labelers on GUDID
Single‑use98%of device records
Sterile98%labelled sterile
Prescription86%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Caldera Medical, Inc.2036%
Boston Scientific Corporation1527%
Ethicon Sàrl712%
Cl Medical59%
Athena Surgical Llc35%
Desarrollo E Investigacion Medica Aragonesa Sl35%
Coloplast A/S24%
Urocure Llc12%

Top labelers

CompanyDevicesShare
Caldera Medical, Inc.2036%
Boston Scientific Corporation1527%
Ethicon Sàrl712%
Cl Medical59%
Athena Surgical Llc35%
Desarrollo E Investigacion Medica Aragonesa Sl35%
Coloplast A/S24%
Urocure Llc12%

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

Brand names on the register (sample)

SuprisAltisI-STOPDesara OneDesara TVDesaraDesara Blue TVDesara SLDesara Blue Short Suture SlingDesara Blue OVDesara BlueDesara Blue TVez 2.7Desara TVez 3.0Desara TVez 2.7Desara Blue TVez 3.0Desara Blue SL

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

FDA product codes

CodeNameDevices
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinar35
OTNmesh, surgical, synthetic, urogynecologic, for stress urinar32
PWJInstrumentation, Surgical Mesh, Urogynecologic, Stress Urina10
PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinar6
OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vagina5
PAHmesh, surgical, synthetic, urogynecologic, for stress urinar3

GMDN & GCC registration

  • GMDN code 47986 · implantable
  • Single‑use 98% · sterile 98% · Rx‑only 86% · 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) · 2Length (Centimeter) · 2

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

No closely related category with 50+ devices.

How many female stress urinary incontinence surgical mesh-sling, synthetic polymer 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 "Female stress urinary incontinence surgical mesh-sling, synthetic polymer", from 8 companies. The largest labeler is Caldera Medical, Inc. with 36% of records.

Which FDA product codes apply?

OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinar), OTN (mesh, surgical, synthetic, urogynecologic, for stress urinar), PWJ (Instrumentation, Surgical Mesh, Urogynecologic, Stress Urina), PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinar)

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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