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Device Explorer · FDA GUDID · GMDN 35296

Nasal file/rasp

A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece ins

US‑registered devices740in commercial distribution
Companies33labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Ambler Surgical Corp.10014%
Novo Surgical, Inc.7710%
Avalign Technologies, Inc.547%
Spiggle & Theis Medizintechnik Gmbh527%
Integra Lifesciences Production Corporation527%
Sontec Instruments, Inc.466%
Fentex Medical Gmbh456%
Rz-Medizintechnik Gmbh426%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.10014%
Novo Surgical, Inc.7710%
Avalign Technologies, Inc.547%
Spiggle & Theis Medizintechnik Gmbh527%
Integra Lifesciences Production Corporation527%
Sontec Instruments, Inc.466%
Fentex Medical Gmbh456%
Rz-Medizintechnik Gmbh426%
Teleflex Incorporated334%
Kls-Martin L.P.314%
Med Saver, Inc.264%
Karl Storz Gmbh & Co. Kg253%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

STILLE RaspsJoseph nasal raspMasing nasal raspNasal raspRasp insertWiener antrum raspAufricht glabella raspFomon nasal raspInsert for rasp, TCInsert for raspKeyFENTEXCottle nasal raspMaltz nasal raspAnderson nasal rasp,Anderson nasal rasp

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

FDA product codes

CodeNameDevices
KBARASP, NASAL374
LRCINSTRUMENT, ENT MANUAL SURGICAL122
KBARasp, Nasal94
GACRASP, SURGICAL, GENERAL & PLASTIC SURGERY41
JYYRASP, EAR27
HTRRASP21

GMDN & GCC registration

  • GMDN code 35296 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 88% · 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) · 48Length (Centimeter) · 11Width (Millimeter) · 4Length (Millimeter) · 3Angle (degree) · 1

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

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

740 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nasal file/rasp", from 33 companies. The largest labeler is Ambler Surgical Corp. with 14% of records.

Which FDA product codes apply?

KBA (RASP, NASAL), LRC (INSTRUMENT, ENT MANUAL SURGICAL), KBA (Rasp, Nasal), GAC (RASP, SURGICAL, GENERAL & PLASTIC SURGERY)

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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