Consulting Wallah › Device Explorer › Other devices › Cranial bur, reusable
Device Explorer · FDA GUDID · GMDN 10520

Cranial bur, reusable

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 devices52in commercial distribution
Companies2labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Medicon Eg. Chirurgiemechaniker-Genossenschaft4790%
Integra Lifesciences Production Corporation510%

Top labelers

CompanyDevicesShare
Medicon Eg. Chirurgiemechaniker-Genossenschaft4790%
Integra Lifesciences Production Corporation510%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MediconMedicon Epiplating SystemIntegra® Jarit®

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

FDA product codes

CodeNameDevices
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES42
HBGDRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)5
JEYPLATE, BONE4
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces1

GMDN & GCC registration

  • GMDN code 10520 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 92% · 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

No structured size data on the register.

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

How many cranial bur, reusable products are registered in the US?

52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cranial bur, reusable", from 2 companies. The largest labeler is Medicon Eg. Chirurgiemechaniker-Genossenschaft with 90% of records.

Which FDA product codes apply?

HWE (INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES), HBG (DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)), JEY (PLATE, BONE), HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Acces)

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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