Consulting Wallah › Device Explorer › Other devices › Cranial bur, single-use
Device Explorer · FDA GUDID · GMDN 46269

Cranial bur, single-use

A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece th

US‑registered devices892in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Stryker Corporation73082%
Adeor Medical Ag9511%
Bien-Air Surgery Sa485%
Nakanishi Inc.61%
Synthes Gmbh61%
Kirwan Surgical Products Llc30%
Medos International Sàrl20%
Karl Storz Gmbh & Co. Kg10%

Top labelers

CompanyDevicesShare
Stryker Corporation73082%
Adeor Medical Ag9511%
Bien-Air Surgery Sa485%
Nakanishi Inc.61%
Synthes Gmbh61%
Kirwan Surgical Products Llc30%
Medos International Sàrl20%
Karl Storz Gmbh & Co. Kg10%
Mako Surgical Corp.10%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AiBurNAZyphrNSK Sterile Burs/DrillsPMT Drill CutterHiCUT Bursn.a.MakoKirwanBur PM2-150 80K Mstick Ø1.8 StBur PM2-150 80K Mstick Ø3.0 StBur Cranial Straight 10mm StBur Cranial Spiral 10mm StBur Cranial Spiral 25mm StBur Cranial Straight 25 mm St

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

FDA product codes

CodeNameDevices
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1,436
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP405
HBCMOTOR, DRILL, ELECTRIC340
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)161
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED87
HBFDRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)87

GMDN & GCC registration

  • GMDN code 46269 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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) · 176Length (Centimeter) · 1

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

How many cranial bur, single-use products are registered in the US?

892 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cranial bur, single-use", from 9 companies. The largest labeler is Stryker Corporation with 82% of records.

Which FDA product codes apply?

HBE (DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)), ERL (DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP), HBC (MOTOR, DRILL, ELECTRIC), HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))

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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