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Device Explorer · FDA GUDID · GMDN 13291

Plastic surgery file/rasp

A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at its working end(s) designed to scrape and smooth the surface of hard tissues (e.g., bone, cartilage) during plastic surgery (e.g., rhinoplasty, face lifting). It

US‑registered devices227in commercial distribution
Companies15labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Integra Lifesciences Production Corporation7031%
Hayden Medical, Inc.4018%
Hnm Stainless, Llc.2712%
Steris Corporation2310%
Black & Black Surgical, Inc.188%
Sontec Instruments, Inc.104%
Novo Surgical, Inc.84%
Integra Microfrance84%

Top labelers

CompanyDevicesShare
Integra Lifesciences Production Corporation7031%
Hayden Medical, Inc.4018%
Hnm Stainless, Llc.2712%
Steris Corporation2310%
Black & Black Surgical, Inc.188%
Sontec Instruments, Inc.104%
Novo Surgical, Inc.84%
Integra Microfrance84%
Avalign Technologies, Inc.73%
Aesculap, Inc.63%
Ambler Surgical Corp.31%
Rz-Medizintechnik Gmbh21%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RZ Medizintechnik GmbHAESCULAPHNM MEDICALNovo Surgical Inc.BLACK & BLACK SURGICAL, INC.Hayden MedicalgSourceSnowden-PencerFomon RaspFOMON RASPFOMON RASPATORYMillenniumAvalignAmbler SurgicalV. MuellerIntegra® Miltex®

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 SURGERY145
GACRasp, Surgical, General & Plastic Surgery27
HTRRasp21
KBARASP, NASAL15
HTRRASP13
GEGElevator, Surgical, General & Plastic Surgery9

GMDN & GCC registration

  • GMDN code 13291 · non‑implantable
  • Single‑use 4% · sterile 0% · 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

Length (Inch) · 20Width (Millimeter) · 2Length (Millimeter) · 2

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

How many plastic surgery file/rasp products are registered in the US?

227 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Plastic surgery file/rasp", from 15 companies. The largest labeler is Integra Lifesciences Production Corporation with 31% of records.

Which FDA product codes apply?

GAC (RASP, SURGICAL, GENERAL & PLASTIC SURGERY), GAC (Rasp, Surgical, General & Plastic Surgery), HTR (Rasp), KBA (RASP, NASAL)

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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