Consulting Wallah › Device Explorer › Wound care & sutures › Barbed polyester suture, antimicrobial
Device Explorer · FDA GUDID · GMDN 64234

Barbed polyester suture, antimicrobial

A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester, and containing an agent to locally inhibit bacterial growth, intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs alo

US‑registered devices262in commercial distribution
Companies1labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Ethicon, Llc262100%

Top labelers

CompanyDevicesShare
Ethicon, Llc262100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

STRATAFIX

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

FDA product codes

CodeNameDevices
NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE130
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID75
NEWSuture, surgical, absorbable, polydioxanone42
GAMSuture, absorbable, synthetic, polyglycolic acid15

GMDN & GCC registration

  • GMDN code 64234 · implantable
  • Single‑use 100% · sterile 100% · 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

No structured size data on the register.

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

How many barbed polyester suture, antimicrobial products are registered in the US?

262 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Barbed polyester suture, antimicrobial", from 1 companies. The largest labeler is Ethicon, Llc with 100% of records.

Which FDA product codes apply?

NEW (SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE), GAM (SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID), NEW (Suture, surgical, absorbable, polydioxanone), GAM (Suture, absorbable, synthetic, polyglycolic acid)

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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