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Device Explorer · FDA GUDID · GMDN 58776

Surgical screwdriver, single-use

A non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted

US‑registered devices438in commercial distribution
Companies39labelers on GUDID
Single‑use96%of device records
Sterile31%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Osstem Implant Co., Ltd.23754%
Pb Swiss Tools Ag4210%
Fusion Orthopedics, Llc215%
Smith & Nephew, Inc.123%
Kls-Martin L.P.123%
Skeletal Dynamics L.L.C.123%
Medartis Inc.123%
Arthrex, Inc.92%

Top labelers

CompanyDevicesShare
Osstem Implant Co., Ltd.23754%
Pb Swiss Tools Ag4210%
Fusion Orthopedics, Llc215%
Smith & Nephew, Inc.123%
Kls-Martin L.P.123%
Skeletal Dynamics L.L.C.123%
Medartis Inc.123%
Arthrex, Inc.92%
Crossroads Extremity Systems92%
Bio Concept Co., Ltd.82%
Biomet Orthopedics, Llc72%
J.M. Longyear Manufacturing, Llc61%

Company = labeler of record on GUDID. 39 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OPERACEANKYLOS®OSSIO® InserterSR Tip,Φ1.95mm,L 18.5mmSR Tip,Φ1.95mm,L 13.5mmSR Tip,Φ1.3mm,L 21.5mmSR Tip,Φ1.3mm,L 16.5mmSR Tip,Φ1.0mm, L 26mmSR Tip,Φ1.0mm,L 20.6mmMini Screw Removal Tip,longMini Screw Removal Tip,ShortNewclip InstrumentsAequalis Reversed IITRIGENMICAFastFrame™

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

FDA product codes

CodeNameDevices
NDPAccessories, Implant, Dental, Endosseous244
HXXScrewdriver82
LXHOrthopedic Manual Surgical Instrument22
HXXSCREWDRIVER20
GXLScrewdriver, Skullplate15
HWRDriver, Prosthesis12

GMDN & GCC registration

  • GMDN code 58776 · non‑implantable
  • Single‑use 96% · sterile 31% · Rx‑only 96% · 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

No structured size data on the register.

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

How many surgical screwdriver, single-use products are registered in the US?

438 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical screwdriver, single-use", from 39 companies. The largest labeler is Osstem Implant Co., Ltd. with 54% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), HXX (Screwdriver), LXH (Orthopedic Manual Surgical Instrument), HXX (SCREWDRIVER)

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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