Consulting Wallah › Device Explorer › Other devices › Surgical torque wrench adaptor
Device Explorer · FDA GUDID · GMDN 61946

Surgical torque wrench adaptor

A component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use

US‑registered devices283in commercial distribution
Companies19labelers on GUDID
Single‑use41%of device records
Sterile2%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Blue Sky Bio Llc20071%
Elos Medtech Pinol A/S228%
Highridge Medical, Llc124%
Talladium España Sl114%
Paragon Implant Mfg., Llc104%
Southern Implants (Pty) Ltd72%
Degen Medical, Inc.52%
Suncoast Dental, Inc31%

Top labelers

CompanyDevicesShare
Blue Sky Bio Llc20071%
Elos Medtech Pinol A/S228%
Highridge Medical, Llc124%
Talladium España Sl114%
Paragon Implant Mfg., Llc104%
Southern Implants (Pty) Ltd72%
Degen Medical, Inc.52%
Suncoast Dental, Inc31%
American Dental Implant Corporation21%
Ceramtec Schweiz Gmbh21%
Coho Biomedical Technology Co., Ltd.10%
Zimvie Us Corp Llc10%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAHigh torque ISO Hex AdapterElos DriverDriver, 4mm HexH-TIRW STANDARD 4mm SQUARE ADAPTERL-TIRW SHORT ISO 1797 ADAPTERL-TIRW STANDARD ISO 1797 ADAPTERISO Adapter For Multi wrenchSquare Adapter For Multi wrenchElos DriverTorque Wrench EV Restorative Driver Handle 4 ×4 Torque Wrench EV Restorative Driver Handle LowTorque Wrench EV Restorative Driver HandleTorque Wrench EV Surgical Driver HandleZiboneBacFix Ti Spinal Fixation System

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

FDA product codes

CodeNameDevices
EBLPin, Retentive And Splinting, And Accessory Instruments188
NDPAccessories, Implant, Dental, Endosseous72
LXHOrthopedic manual surgical instrument13
OLOOrthopedic stereotaxic instrument4
LXHOrthopedic Manual Surgical Instrument3
HXCWrench2

GMDN & GCC registration

  • GMDN code 61946 · non‑implantable
  • Single‑use 41% · sterile 2% · Rx‑only 97% · 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

Outer Diameter (Millimeter) · 11Length (Millimeter) · 11

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

How many surgical torque wrench adaptor 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 "Surgical torque wrench adaptor", from 19 companies. The largest labeler is Blue Sky Bio Llc with 71% of records.

Which FDA product codes apply?

EBL (Pin, Retentive And Splinting, And Accessory Instruments), NDP (Accessories, Implant, Dental, Endosseous), LXH (Orthopedic manual surgical instrument), OLO (Orthopedic stereotaxic instrument)

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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