Consulting Wallah › Device Explorer › Syringes, needles & infusion › Suturing needle, single-use
Device Explorer · FDA GUDID · GMDN 61143

Suturing needle, single-use

A cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatur

US‑registered devices416in commercial distribution
Companies22labelers on GUDID
Single‑use99%of device records
Sterile82%labelled sterile
Prescription33%Rx‑only share
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Share of device records

Aspen Surgical Products, Inc.25662%
Integra Lifesciences Production Corporation6816%
Aros Surgical Instruments Corporation225%
Riverpoint Medical, Llc154%
Arthrex, Inc.143%
Smith & Nephew, Inc.102%
Biomet Orthopedics, Llc61%
Conmed Corporation41%

Top labelers

CompanyDevicesShare
Aspen Surgical Products, Inc.25662%
Integra Lifesciences Production Corporation6816%
Aros Surgical Instruments Corporation225%
Riverpoint Medical, Llc154%
Arthrex, Inc.143%
Smith & Nephew, Inc.102%
Biomet Orthopedics, Llc61%
Conmed Corporation41%
Volmed Brasil Equipamentos Ltda31%
Cayenne Medical, Inc.20%
Lincotek Medical Llc20%
Tornier, Inc.20%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InjectorCROSSTRACFAST-FIXNAArthrex®RC NeedleMini RC NeedleQuattro® Suture Passer NeedleTRUEPASSRC NEEDLECURVTEK EYE NEEDLEVersipass Suture Passer NeedleChampion Suture Passer NeedleTigon MedicalArthroPassGrice Laparoscopic Suture Needle

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

FDA product codes

CodeNameDevices
GABNEEDLE, SUTURING, DISPOSABLE338
DXCCLAMP, VASCULAR21
HWQPasser15
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE9
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT8
GABNeedle, Suturing, Disposable7

GMDN & GCC registration

  • GMDN code 61143 · non‑implantable
  • Single‑use 99% · sterile 82% · Rx‑only 33% · 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) · 22Length (Inch) · 2Width (Inch) · 1Height (Inch) · 1Depth (Inch) · 1

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

How many suturing needle, single-use products are registered in the US?

416 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Suturing needle, single-use", from 22 companies. The largest labeler is Aspen Surgical Products, Inc. with 62% of records.

Which FDA product codes apply?

GAB (NEEDLE, SUTURING, DISPOSABLE), DXC (CLAMP, VASCULAR), HWQ (Passer), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE)

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.

How do I get quotes?

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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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