Consulting Wallah › Device Explorer › Wound care & sutures › Polyolefin/fluoropolymer suture, monofilament
Device Explorer · FDA GUDID · GMDN 13909

Polyolefin/fluoropolymer suture, monofilament

A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tiss

US‑registered devices5,711in commercial distribution
Companies50labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription89%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Demetech Corporation1,90933%
Ethicon, Llc90816%
Covidien Lp3967%
Teleflex Incorporated3837%
Peters Surgical3546%
Foosin Medical Supplies Inc., Ltd.3466%
Surgical Specialties México, S. De R.L. De C.V.2885%
Internacional Farmacéutica, S.A. De C.V.1402%

Top labelers

CompanyDevicesShare
Demetech Corporation1,90933%
Ethicon, Llc90816%
Covidien Lp3967%
Teleflex Incorporated3837%
Peters Surgical3546%
Foosin Medical Supplies Inc., Ltd.3466%
Surgical Specialties México, S. De R.L. De C.V.2885%
Internacional Farmacéutica, S.A. De C.V.1402%
Meril Endo Surgery Private Limited1242%
W. L. Gore & Associates, Inc.1142%
C.P. Medical Corporation932%
Riverpoint Medical, Llc781%

Company = labeler of record on GUDID. 50 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ATRAMATRTMEDWEGO-Polypropylene Nonabsorbable Surgical SutureDigitexAPTOSCross-SealPremileneFIXTCAPIODEKNATELMOPYLENCOROLENE®Darby Dental Supply, LLCSurgipro IITigon MedicalGolnit PTFE Suture

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

FDA product codes

CodeNameDevices
GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4,234
GAWSuture, Nonabsorbable, Synthetic, Polypropylene2,886
GAWSuture, nonabsorbable, synthetic, polypropylene602
NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroet394
PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Sutu40
NBYSUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROET29

GMDN & GCC registration

  • GMDN code 13909 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 89% · 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) · 2,849Length (Inch) · 651Length (Millimeter) · 150Outer Diameter (Millimeter) · 48Angle (degree) · 11Length (Micrometer) · 1

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

How many polyolefin/fluoropolymer suture, monofilament products are registered in the US?

5,711 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polyolefin/fluoropolymer suture, monofilament", from 50 companies. The largest labeler is Demetech Corporation with 33% of records.

Which FDA product codes apply?

GAW (SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE), GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), GAW (Suture, nonabsorbable, synthetic, polypropylene), NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroet)

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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