Device Explorer · FDA GUDID · GMDN 35090

Surgical gouge

A heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp

US‑registered devices1,764in commercial distribution
Companies49labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Sklar Corporation34520%
Life Instrument Corporation1338%
Karl Storz Gmbh & Co. Kg1257%
Novo Surgical, Inc.1096%
Aspen Surgical Products, Inc.965%
Gsource Llc925%
Integra Lifesciences Production Corporation885%
Med Saver, Inc.865%

Top labelers

CompanyDevicesShare
Sklar Corporation34520%
Life Instrument Corporation1338%
Karl Storz Gmbh & Co. Kg1257%
Novo Surgical, Inc.1096%
Aspen Surgical Products, Inc.965%
Gsource Llc925%
Integra Lifesciences Production Corporation885%
Med Saver, Inc.865%
Surtex Instruments Ltd.835%
Avalign Technologies, Inc.664%
Ortho-Med, Inc.593%
Highridge Medical, Llc533%

Company = labeler of record on GUDID. 49 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTNACapener Lamina Gouge, Cranked, 240mm O/L, 13mm WCapener Lamina Gouge, Cranked, 240mm O/L, 16mm WCapener Lamina Gouge, Cranked, 240mm O/L, 6mm WiSwan Neck Gouge, 320mm O/L, 25mm WidthSurtexFENTEXSCHWERTRZ Medizintechnik GmbHGimmin.a.AESCULAPLubinus Classic Plus Hip Stem - InstrumentsLINK Instruments - Chisel, bone curette, raspatoInstruments for Revision Surgery

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

FDA product codes

CodeNameDevices
GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY804
GDHGouge, Surgical, General & Plastic Surgery422
EMMCHISEL, OSTEOTOME, SURGICAL176
LRCINSTRUMENT, ENT MANUAL SURGICAL115
LXHOrthopedic manual surgical instrument55
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT54

GMDN & GCC registration

  • GMDN code 35090 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 54% · 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) · 170Width (Millimeter) · 108Width (Inch) · 56Height (Millimeter) · 42Length (Centimeter) · 22Length (Millimeter) · 2

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

How many surgical gouge products are registered in the US?

1,764 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical gouge", from 49 companies. The largest labeler is Sklar Corporation with 20% of records.

Which FDA product codes apply?

GDH (GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY), GDH (Gouge, Surgical, General & Plastic Surgery), EMM (CHISEL, OSTEOTOME, SURGICAL), LRC (INSTRUMENT, ENT MANUAL SURGICAL)

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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