Consulting Wallah › Device Explorer › Orthopaedic implants › Surgical screwdriver, single-use, non-sterile
Device Explorer · FDA GUDID · GMDN 47633

Surgical screwdriver, single-use, non-sterile

A non-sterile, 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 m

US‑registered devices99in commercial distribution
Companies13labelers on GUDID
Single‑use43%of device records
Sterile0%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Sin Sistema De Implante Nacional S/A4444%
Advanced Orthopaedic Solutions, Inc.1414%
Biomet Orthopedics, Llc1111%
Fusion Orthopedics, Llc1010%
Dentsply Implants Manufacturing Gmbh55%
Ace Surgical Supply Co., Inc.33%
Biopro, Inc.33%
Neurovention Llc33%

Top labelers

CompanyDevicesShare
Sin Sistema De Implante Nacional S/A4444%
Advanced Orthopaedic Solutions, Inc.1414%
Biomet Orthopedics, Llc1111%
Fusion Orthopedics, Llc1010%
Dentsply Implants Manufacturing Gmbh55%
Ace Surgical Supply Co., Inc.33%
Biopro, Inc.33%
Neurovention Llc33%
Etgar - Medical Instruments Ltd22%
Osteomed Llc11%
Preat Corporation11%
Camber Spine Technologies, Llc11%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ANKYLOS®Astra Tech Implant System®Pin Driver HexThru Hex DriverProximal Nail Extractor BoltHEX EXTRACTOR, HUDSONEASY OUT, S-COUPLEPROXIMAL NAIL EXTRACTOR BOLTSOLIDLOK™HEX TIPHEX EXTRACTORHEX EXTRACTOR, LONG HUDSONEASYOUTT15 SOLID HEX DRIVERT15 DRIVER (AO STYLE)T15 SCREW DRIVERCaptured T10 Screwdriver, Short

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

FDA product codes

CodeNameDevices
KCTSterilization Wrap Containers, Trays, Cassettes & Other Acce44
LXHOrthopedic Manual Surgical Instrument14
HWCScrew, Fixation, Bone10
HXXSCREWDRIVER7
NDPAccessories, implant, dental, endosseous6
HWBEXTRACTOR3

GMDN & GCC registration

  • GMDN code 47633 · non‑implantable
  • Single‑use 43% · sterile 0% · Rx‑only 91% · 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 (Millimeter) · 1

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

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

99 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical screwdriver, single-use, non-sterile", from 13 companies. The largest labeler is Sin Sistema De Implante Nacional S/A with 44% of records.

Which FDA product codes apply?

KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Acce), LXH (Orthopedic Manual Surgical Instrument), HWC (Screw, Fixation, Bone), 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.

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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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