Consulting Wallah › Device Explorer › Other devices › General/plastic surgery bur
Device Explorer · FDA GUDID · GMDN 46392

General/plastic surgery bur

A small rotary shaft of hard metal (e.g., steel) with fluting or cutting planes of various shapes on one end, designed to excavate soft tissue or cartilage during general and/or plastic surgery. It is usually power-driven by a rotary handpiece or other powered

US‑registered devices96in commercial distribution
Companies3labelers on GUDID
Single‑use6%of device records
Sterile6%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Medicon Eg. Chirurgiemechaniker-Genossenschaft8285%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung88%
Centurion Medical Products Corporation66%

Top labelers

CompanyDevicesShare
Medicon Eg. Chirurgiemechaniker-Genossenschaft8285%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung88%
Centurion Medical Products Corporation66%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mediconn/aCenturion

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 ACCES63
HXYBRACE, DRILL11
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY7
EJLBUR, DENTAL6
JEYPLATE, BONE5
JYOKNIFE, EAR3

GMDN & GCC registration

  • GMDN code 46392 · non‑implantable
  • Single‑use 6% · sterile 6% · 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

No structured size data on the register.

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

How many general/plastic surgery bur products are registered in the US?

96 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General/plastic surgery bur", from 3 companies. The largest labeler is Medicon Eg. Chirurgiemechaniker-Genossenschaft with 85% of records.

Which FDA product codes apply?

HWE (INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES), HXY (BRACE, DRILL), GFF (BUR, SURGICAL, GENERAL & PLASTIC SURGERY), EJL (BUR, DENTAL)

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.

How do I get quotes?

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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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