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Device Explorer · FDA GUDID · GMDN 35131

Amputation knife

A hand-held manual surgical instrument with a handle and a heavy single-edged or double-edged blade, of various shapes and sizes, used in surgery for the amputation of a limb. It is typically a one-piece instrument made of high-grade stainless steel. This is a

US‑registered devices58in commercial distribution
Companies16labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Medicon Eg. Chirurgiemechaniker-Genossenschaft1119%
Avalign Technologies, Inc.814%
American Medicals712%
Sklar Corporation712%
Ambler Surgical Corp.47%
Teleflex Incorporated47%
Integra Lifesciences Production Corporation47%
Gimmi Gmbh23%

Top labelers

CompanyDevicesShare
Medicon Eg. Chirurgiemechaniker-Genossenschaft1119%
Avalign Technologies, Inc.814%
American Medicals712%
Sklar Corporation712%
Ambler Surgical Corp.47%
Teleflex Incorporated47%
Integra Lifesciences Production Corporation47%
Gimmi Gmbh23%
Gsource Llc23%
Steris Corporation23%
Novo Surgical, Inc.23%
Aspen Surgical Products, Inc.12%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GimmiMediconSymmetry ListonGEN2gSourceCuraplexMSIAdler Instrument CompanyMillenniumMILLENNIUMAvalignAmbler SurgicalAmerican MedicalsKMEDICPILLINGV. Mueller

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

FDA product codes

CodeNameDevices
GDNKNIFE, AMPUTATION25
EMFKNIFE, SURGICAL15
GDNKnife, Amputation13
EMFKnife, Surgical3
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL2
HRQHEMOSTAT1

GMDN & GCC registration

  • GMDN code 35131 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 71% · 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 (Millimeter) · 4Length (Inch) · 3Length (Centimeter) · 3

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

No closely related category with 50+ devices.

How many amputation knife products are registered in the US?

58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Amputation knife", from 16 companies. The largest labeler is Medicon Eg. Chirurgiemechaniker-Genossenschaft with 19% of records.

Which FDA product codes apply?

GDN (KNIFE, AMPUTATION), EMF (KNIFE, SURGICAL), GDN (Knife, Amputation), EMF (Knife, 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.

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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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