Device Explorer · FDA GUDID · GMDN 35141

Scalpel, reusable

A hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusa

US‑registered devices718in commercial distribution
Companies37labelers on GUDID
Single‑use5%of device records
Sterile4%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Karl Storz Gmbh & Co. Kg12918%
Surtex Instruments Ltd.12618%
Aesculap Ag10915%
Rz-Medizintechnik Gmbh588%
Peter Lazic Gmbh477%
Gsource Llc466%
Medicon Eg. Chirurgiemechaniker-Genossenschaft294%
Richard Wolf Gmbh264%

Top labelers

CompanyDevicesShare
Karl Storz Gmbh & Co. Kg12918%
Surtex Instruments Ltd.12618%
Aesculap Ag10915%
Rz-Medizintechnik Gmbh588%
Peter Lazic Gmbh477%
Gsource Llc466%
Medicon Eg. Chirurgiemechaniker-Genossenschaft294%
Richard Wolf Gmbh264%
Katalyst Surgical Llc243%
Integra Lifesciences Production Corporation183%
Fentex Medical Gmbh132%
Sopro-Comeg Gmbh101%

Company = labeler of record on GUDID. 37 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dr.Paleys Osteotomy SystemSurtexCP ANGLED SUPER MICRO-DISSECTORSDISSECTORLAZICFENTEXUrethrotomy knifeArthroscopy hand instrumentsVERTEBRISNARZ Medizintechnik GmbHGimmin.a.ROTOCUTAESCULAPNOIR

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

FDA product codes

CodeNameDevices
EMFKNIFE, SURGICAL190
EMFKnife, Surgical76
LRCINSTRUMENT, ENT MANUAL SURGICAL68
EZOUrethrotome55
HTSKnife, Orthopedic46
GZXINSTRUMENT, MICROSURGICAL45

GMDN & GCC registration

  • GMDN code 35141 · non‑implantable
  • Single‑use 5% · sterile 4% · Rx‑only 67% · 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) · 29Outer Diameter (Millimeter) · 21Width (Millimeter) · 2Length (Inch) · 1

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

How many scalpel, reusable products are registered in the US?

718 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Scalpel, reusable", from 37 companies. The largest labeler is Karl Storz Gmbh & Co. Kg with 18% of records.

Which FDA product codes apply?

EMF (KNIFE, SURGICAL), EMF (Knife, Surgical), LRC (INSTRUMENT, ENT MANUAL SURGICAL), EZO (Urethrotome)

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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