Consulting Wallah › Device Explorer › Syringes, needles & infusion › Suturing needle holder, reusable
Device Explorer · FDA GUDID · GMDN 12726

Suturing needle holder, reusable

A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of t

US‑registered devices16,367in commercial distribution
Companies171labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription62%Rx‑only share
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Share of device records

Sontec Instruments, Inc.8925%
Ambler Surgical Corp.8305%
Wexler Surgical, Inc.7405%
Integra Lifesciences Production Corporation6684%
Sklar Corporation6534%
Novo Surgical, Inc.5593%
Emi Factory Co., Ltd.5443%
Steris Corporation5403%

Top labelers

CompanyDevicesShare
Sontec Instruments, Inc.8925%
Ambler Surgical Corp.8305%
Wexler Surgical, Inc.7405%
Integra Lifesciences Production Corporation6684%
Sklar Corporation6534%
Novo Surgical, Inc.5593%
Emi Factory Co., Ltd.5443%
Steris Corporation5403%
Scanlan International Inc4673%
Aspen Surgical Products, Inc.4603%
Avalign Technologies, Inc.4593%
Surgical Direct, Inc.4333%

Company = labeler of record on GUDID. 171 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAInjectorSTILLE Titanium Micro Needle HoldersSTILLE Micro Needle HoldersSTILLE Needle HoldersVersius Needle HolderSurtexDuckworth & KentDual Needle HolderCEA Thin Needle Holder 170 mmEMI P Flap Micro Needle HolderEMI Dental Micro Needle HolderEMI Super Micro TAKUMI ModelEMI Super Micro Needle Holder CompoundEMI Super Micro Needle HolderYukimura

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

FDA product codes

CodeNameDevices
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC3,896
FHQHolder, Needle, Gastroenterologic3,408
HXKHOLDER, NEEDLE; ORTHOPEDIC1,975
DWSInstruments, Surgical, Cardiovascular1,054
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE959
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR936

GMDN & GCC registration

  • GMDN code 12726 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 62% · OTC 1%
  • 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) · 1,620Length (Centimeter) · 714Width (Millimeter) · 106Length (Millimeter) · 101Outer Diameter (Millimeter) · 49Lumen/Inner Diameter (Millimeter) · 2

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

How many suturing needle holder, reusable products are registered in the US?

16,367 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Suturing needle holder, reusable", from 171 companies. The largest labeler is Sontec Instruments, Inc. with 5% of records.

Which FDA product codes apply?

FHQ (HOLDER, NEEDLE, GASTROENTEROLOGIC), FHQ (Holder, Needle, Gastroenterologic), HXK (HOLDER, NEEDLE; ORTHOPEDIC), DWS (Instruments, Surgical, Cardiovascular)

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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