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Device Explorer · FDA GUDID · GMDN 47563

Fluted surgical drill bit, single-use, non-sterile

"A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a ""twist drill"", has a cylindrical design with a do

US‑registered devices382in commercial distribution
Companies24labelers on GUDID
Single‑use94%of device records
Sterile8%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc10628%
Advanced Orthopaedic Solutions, Inc.4111%
Orthopaedic Implant Company, The308%
Vilex Llc287%
Kalitec Direct Llc277%
Simpex Medical, Inc.257%
Ortho Solutions Holdings Limited246%
Osteomed Llc246%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc10628%
Advanced Orthopaedic Solutions, Inc.4111%
Orthopaedic Implant Company, The308%
Vilex Llc287%
Kalitec Direct Llc277%
Simpex Medical, Inc.257%
Ortho Solutions Holdings Limited246%
Osteomed Llc246%
Orthofix Srl185%
Meditech Spine, Llc154%
Park Dental Research Corp82%
Miami Device Solutions Llc62%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CyclaPlex Drill Bits 1.8-3.0PontoORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS ULTOS PLATING SYSTEMACUFEXOrthopedic1.5MM DRILL BITDFS FIXATORSOLID DRILL BITCALIBRATED DRILL BITSOLID DRILLMARKED DRILL BIT SHORTA.L.P.S.®DRIVER BITDRILL BIT MINI QUICK CONNECTDRILL BIT MINI QUICK CONNECT F.A.S.T.

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

FDA product codes

CodeNameDevices
HTWBit, Drill100
HTWBIT, DRILL98
HWCScrew, Fixation, Bone52
LXHOrthopedic Manual Surgical Instrument41
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces19
HRSPlate, Fixation, Bone19

GMDN & GCC registration

  • GMDN code 47563 · non‑implantable
  • Single‑use 94% · sterile 8% · 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

Outer Diameter (Millimeter) · 87Length (Millimeter) · 53Width (Millimeter) · 1

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

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

382 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fluted surgical drill bit, single-use, non-sterile", from 24 companies. The largest labeler is Biomet Orthopedics, Llc with 28% of records.

Which FDA product codes apply?

HTW (Bit, Drill), HTW (BIT, DRILL), HWC (Screw, Fixation, Bone), LXH (Orthopedic Manual Surgical 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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