Consulting Wallah › Device Explorer › Wound care & sutures › Polyester suture, non-bioabsorbable, monofilament
Device Explorer · FDA GUDID · GMDN 17245

Polyester suture, non-bioabsorbable, monofilament

A single-strand (monofilament), synthetic thread made from a non-bioabsorbable polyester (e.g., polybutester) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached d

US‑registered devices132in commercial distribution
Companies4labelers on GUDID
Single‑use97%of device records
Sterile89%labelled sterile
Prescription96%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Covidien Lp11789%
Endure Industries108%
A. Titan Instruments, Inc.43%
Applied Dental, Inc.11%

Top labelers

CompanyDevicesShare
Covidien Lp11789%
Endure Industries108%
A. Titan Instruments, Inc.43%
Applied Dental, Inc.11%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NovafilA. Titan InstrumentsENDURE INDUSTRIESUNIFY PTFE Surgical SuturesV-LocSynetureVascufil

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

FDA product codes

CodeNameDevices
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE195
NWJSuture, recombinant technology12
GAWSuture, Nonabsorbable, Synthetic, Polypropylene10
KDDKit, Surgical Instrument, Disposable4
NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroet1

GMDN & GCC registration

  • GMDN code 17245 · implantable
  • Single‑use 97% · sterile 89% · 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 (Inch) · 194Length (Centimeter) · 12

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

How many polyester suture, non-bioabsorbable, monofilament products are registered in the US?

132 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polyester suture, non-bioabsorbable, monofilament", from 4 companies. The largest labeler is Covidien Lp with 89% of records.

Which FDA product codes apply?

GAT (SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE), NWJ (Suture, recombinant technology), GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), KDD (Kit, Surgical Instrument, Disposable)

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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