Consulting Wallah › Device Explorer › Syringes, needles & infusion › Cannulated surgical drill bit, single-use
Device Explorer · FDA GUDID · GMDN 61235

Cannulated surgical drill bit, single-use

A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channe

US‑registered devices1,380in commercial distribution
Companies62labelers on GUDID
Single‑use82%of device records
Sterile51%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Medline Industries, Inc.22917%
Seaspine Orthopedics Corporation1148%
Smith & Nephew, Inc.1048%
T.A.G Medical Products Agricultural Cooperative Association907%
Arthrex, Inc.776%
Tyber Medical, Llc755%
Paragon 28, Inc.564%
Ascension Orthopedics, Inc.514%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.22917%
Seaspine Orthopedics Corporation1148%
Smith & Nephew, Inc.1048%
T.A.G Medical Products Agricultural Cooperative Association907%
Arthrex, Inc.776%
Tyber Medical, Llc755%
Paragon 28, Inc.564%
Ascension Orthopedics, Inc.514%
Microaire Surgical Instruments Llc453%
Fusion Orthopedics, Llc433%
Novastep383%
Degen Medical, Inc.363%

Company = labeler of record on GUDID. 62 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Piccolo Composite Nailing SystemPiccolo Composite Plate SystemORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS STERILE DRILL BITSOrthoSolutions 'System26' Bone ScrewsOXFORD ANKLE FUSION NAIL(AFN) SYSTEMOrtho Solutions Extremity Fixation Implants for De Soutter MedicalAsnisNAIn2BonesIBS™PECA® 2.0airlock®Nexis® MISAirlock®

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

FDA product codes

CodeNameDevices
HTWBIT, DRILL385
GFGBIT, SURGICAL258
HTWBit, Drill213
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL173
MNIORTHOSIS, SPINAL PEDICLE FIXATION172
HTOReamer87

GMDN & GCC registration

  • GMDN code 61235 · non‑implantable
  • Single‑use 82% · sterile 51% · 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) · 149Length (Millimeter) · 97Lumen/Inner Diameter (Millimeter) · 5Outer Diameter (Micrometer) · 1Outer Diameter (Inch) · 1Width (Millimeter) · 1

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

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

1,380 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cannulated surgical drill bit, single-use", from 62 companies. The largest labeler is Medline Industries, Inc. with 17% of records.

Which FDA product codes apply?

HTW (BIT, DRILL), GFG (BIT, SURGICAL), HTW (Bit, Drill), KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL)

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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