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Device Explorer · FDA GUDID · GMDN 37839

Suturing unit, reusable

A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop

US‑registered devices1,146in commercial distribution
Companies44labelers on GUDID
Single‑use5%of device records
Sterile7%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Arthrex, Inc.39434%
George Tiemann & Co.17816%
T.A.G Medical Products Agricultural Cooperative Association11010%
Elmed Incorporated696%
Karl Storz Gmbh & Co. Kg525%
Rz-Medizintechnik Gmbh353%
Smith & Nephew, Inc.353%
Avalign Technologies, Inc.353%

Top labelers

CompanyDevicesShare
Arthrex, Inc.39434%
George Tiemann & Co.17816%
T.A.G Medical Products Agricultural Cooperative Association11010%
Elmed Incorporated696%
Karl Storz Gmbh & Co. Kg525%
Rz-Medizintechnik Gmbh353%
Smith & Nephew, Inc.353%
Avalign Technologies, Inc.353%
Sklar Corporation333%
Sontec Instruments, Inc.313%
Medos International Sàrl202%
Landanger171%

Company = labeler of record on GUDID. 44 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

COBRAFENTEXNARZ Medizintechnik GmbHGimmiSUTURE INSTRUMENTn.a.FETCHERSilGraspSNAPPER / SHOULDER PROWONDERHOOKecoPass SecoPass LMENIXDELACROIX-CHEVALIERLANDANGER

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

FDA product codes

CodeNameDevices
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE315
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT212
LXHOrthopedic Manual Surgical Instrument105
NBHAccessories, arthroscopic99
GCJLaparoscope, General & Plastic Surgery75
LXHOrthopedic manual surgical instrument65

GMDN & GCC registration

  • GMDN code 37839 · non‑implantable
  • Single‑use 5% · sterile 7% · Rx‑only 70% · 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) · 34Length (Millimeter) · 12Outer Diameter (Millimeter) · 10Angle (degree) · 3Length (Centimeter) · 2Width (Millimeter) · 1

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

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

1,146 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Suturing unit, reusable", from 44 companies. The largest labeler is Arthrex, Inc. with 34% of records.

Which FDA product codes apply?

MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic Manual Surgical Instrument), NBH (Accessories, arthroscopic)

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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