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Device Explorer · FDA GUDID · GMDN 43390

Fluted surgical drill bit, single-use

"A 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 double-edged c

US‑registered devices3,490in commercial distribution
Companies108labelers on GUDID
Single‑use95%of device records
Sterile60%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Kls-Martin L.P.3249%
Biomet Orthopedics, Llc2979%
Smith & Nephew, Inc.2447%
Arthrex, Inc.2447%
Medline Industries, Inc.2447%
Stryker Gmbh2337%
Stryker Leibinger Gmbh & Co. Kg1825%
Suretek Medical1755%

Top labelers

CompanyDevicesShare
Kls-Martin L.P.3249%
Biomet Orthopedics, Llc2979%
Smith & Nephew, Inc.2447%
Arthrex, Inc.2447%
Medline Industries, Inc.2447%
Stryker Gmbh2337%
Stryker Leibinger Gmbh & Co. Kg1825%
Suretek Medical1755%
Bioplate, Inc.923%
Nobel Biocare Ab772%
Peter Brasseler Holdings, Llc742%
Ctl Medical Corporation702%

Company = labeler of record on GUDID. 108 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2, PANGEANAPatient-Fitted TMJ Reconstructive Prosthesis SysPANGEAHOFFMANN LRFDeltaT2 ALPHAUNIVERSAL 2ASNIST2INSTRUMENTCinchLock FlexVARIAXSONICFUSIONFIXOSAXSOS

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

FDA product codes

CodeNameDevices
HTWBIT, DRILL1,822
HTWBit, Drill474
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)286
GFGBIT, SURGICAL266
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT198
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES180

GMDN & GCC registration

  • GMDN code 43390 · non‑implantable
  • Single‑use 95% · sterile 60% · Rx‑only 94% · 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) · 1,021Outer Diameter (Millimeter) · 240Length (Inch) · 5Length (Centimeter) · 1Width (Millimeter) · 1

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

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

3,490 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", from 108 companies. The largest labeler is Kls-Martin L.P. with 9% of records.

Which FDA product codes apply?

HTW (BIT, DRILL), HTW (Bit, Drill), HBE (DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)), GFG (BIT, SURGICAL)

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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