Consulting Wallah › Device Explorer › Other devices › Bone file/rasp, reciprocating, single-use
Device Explorer · FDA GUDID · GMDN 64007

Bone file/rasp, reciprocating, single-use

A surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to be attached to a reciprocating power tool handpiece to scrape and smooth the surface of bone during a surgical procedure. It has grooves/teeth along all or part of the d

US‑registered devices130in commercial distribution
Companies9labelers on GUDID
Single‑use86%of device records
Sterile66%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Medline Industries, Inc.4635%
Extremity Medical, Llc2015%
W.H. Holden, Inc.1814%
Vilex Llc129%
Gebr. Brasseler Gmbh & Co. Kg118%
Microaire Surgical Instruments Llc86%
Peter Brasseler Holdings, Llc65%
Conmed Corporation54%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.4635%
Extremity Medical, Llc2015%
W.H. Holden, Inc.1814%
Vilex Llc129%
Gebr. Brasseler Gmbh & Co. Kg118%
Microaire Surgical Instruments Llc86%
Peter Brasseler Holdings, Llc65%
Conmed Corporation54%
Nakanishi Inc.43%

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

Brand names on the register (sample)

NSK Sterile Rasps/FilesBrasseler USABONE FILE HOWARD #67 HD D/EBONE FILE #64X CROSS CUT HD D/EBONE FILE #64 SINGLE CUT HD D/EBONE FILE #52X REVERSE, CROSS CUT HD D/EBONE FILE #52X CROSS CUT HF D/EBONE FILE #52X CROSS CUT HD D/E DLCBONE FILE #52X CROSS CUT HD D/EBONE FILE #52X CROSS CUT OLSEN HANDLE D/E DLC **BONE FILE #52 SINGLE CUT HD D/EBONE FILE #45 SINGLE CUT HD D/EBONE FILE #21X CROSS CUT HD D/EBONE FILE #21 SINGLE CUT H/O D/EBONE FILE #21 SINGLE CUT HF D/EBONE FILE #21 SINGLE CUT HD D/E

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

FDA product codes

CodeNameDevices
GACRASP, SURGICAL, GENERAL & PLASTIC SURGERY32
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces20
EMIFILE, BONE, SURGICAL18
HTRRasp16
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES12
GFABlade, Saw, General & Plastic Surgery, Surgical11

GMDN & GCC registration

  • GMDN code 64007 · non‑implantable
  • Single‑use 86% · sterile 66% · Rx‑only 86% · 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

Width (Millimeter) · 16Length (Millimeter) · 16

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

How many bone file/rasp, reciprocating, single-use products are registered in the US?

130 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone file/rasp, reciprocating, single-use", from 9 companies. The largest labeler is Medline Industries, Inc. with 35% of records.

Which FDA product codes apply?

GAC (RASP, SURGICAL, GENERAL & PLASTIC SURGERY), HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Acces), EMI (FILE, BONE, SURGICAL), HTR (Rasp)

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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