Consulting Wallah › Device Explorer › Syringes, needles & infusion › Suturing needle holder, single-use
Device Explorer · FDA GUDID · GMDN 47568

Suturing needle holder, single-use

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 has short serrated jaws at the distal end to provide better grip of the needle, and is available in

US‑registered devices283in commercial distribution
Companies32labelers on GUDID
Single‑use91%of device records
Sterile64%labelled sterile
Prescription47%Rx‑only share
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Share of device records

Sklar Corporation5319%
Livsmed3412%
Cardinal Health 200, Llc3211%
Dr.Frigz International(Pvt)Ltd,3111%
Diamatrix155%
Blink Medical Limited145%
Trinity Sterile, Inc.145%
Robinson Healthcare Limited124%

Top labelers

CompanyDevicesShare
Sklar Corporation5319%
Livsmed3412%
Cardinal Health 200, Llc3211%
Dr.Frigz International(Pvt)Ltd,3111%
Diamatrix155%
Blink Medical Limited145%
Trinity Sterile, Inc.145%
Robinson Healthcare Limited124%
Crown Surgical Corporation124%
Dtr Medical Limited93%
Medical Action Industries Inc.72%
Elmed Instruments(Pvt)Ltd.62%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sterile,Single Use,Needle Holder,11mm Curved JawNeedle Holder ParkhouseNeedle Holder Derf 12.5cmNeedle Holder TroutmanNeedle Holder Delicate CurveNeedle Holder Castroviejo Without LockNeedle Holder Castroviejo With LockNeedle Halsey Smooth Angled Thumb GripNeedle Holder Nieverts 13cmNeedle Holder Kilner 13cmNeedle Holder Halsey Smooth 13cmNeedle Holder Halsey 13cmNeedle Holder Halsey Smooth Narrow Jaw 13cmNeedle Holder Crilewood 15cmNeedle Holder Mayo 13cmSusol® Needle Holder Kilner

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

FDA product codes

CodeNameDevices
HXKHOLDER, NEEDLE; ORTHOPEDIC69
FHQHolder, Needle, Gastroenterologic40
MDMInstrument, Manual, Surgical, General Use35
GENForceps, General & Plastic Surgery32
GABNEEDLE, SUTURING, DISPOSABLE26
HNRForceps, Ophthalmic16

GMDN & GCC registration

  • GMDN code 47568 · non‑implantable
  • Single‑use 91% · sterile 64% · Rx‑only 47% · OTC 12%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 34Length (Inch) · 31Shaft Length (Millimeter) · 25Length (Centimeter) · 12Shaft Length (Centimeter) · 9

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

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

283 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Suturing needle holder, single-use", from 32 companies. The largest labeler is Sklar Corporation with 19% of records.

Which FDA product codes apply?

HXK (HOLDER, NEEDLE; ORTHOPEDIC), FHQ (Holder, Needle, Gastroenterologic), MDM (Instrument, Manual, Surgical, General Use), GEN (Forceps, General & Plastic Surgery)

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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