Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Manual scalpel blade, single-use
Device Explorer · FDA GUDID · GMDN 37445

Manual scalpel blade, single-use

An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractabl

US‑registered devices1,346in commercial distribution
Companies68labelers on GUDID
Single‑use95%of device records
Sterile89%labelled sterile
Prescription38%Rx‑only share
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Share of device records

Swann-Morton Limited17513%
Surgistar, Inc.14911%
Hmd Healthcare India Private Limited836%
Huaiyin Medical Instruments Co., Ltd.806%
Aditya Dispomed Products Private Limited695%
Stryker Gmbh544%
Sterilance Medical (Suzhou) Inc.524%
Aspen Surgical Products, Inc.463%

Top labelers

CompanyDevicesShare
Swann-Morton Limited17513%
Surgistar, Inc.14911%
Hmd Healthcare India Private Limited836%
Huaiyin Medical Instruments Co., Ltd.806%
Aditya Dispomed Products Private Limited695%
Stryker Gmbh544%
Sterilance Medical (Suzhou) Inc.524%
Aspen Surgical Products, Inc.463%
Jmu Dental, Inc363%
Aesculap Ag343%
Surgical Specialties México, S. De R.L. De C.V.322%
Deroyal Industries, Inc.322%

Company = labeler of record on GUDID. 68 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VersiQuadENDOTRACEDINTRAKENDOTRIGSamuraiMeiyi® Carbon Steel Surgical ScalpelMeiyi® Stainless Steel Surgical ScalpelMeiyi® Stainless steel surgical scalpelSterile Disposable Surgical Blade without PlastiSterile Disposable Surgical Blade without PlastiSwann Morton Ltd.Swann-Morton Ltd.FEATHER SURGICAL BLADE STAINLESS STEELFEATHER DISSECTING BLADEHu-FriedyAESCULAP

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

FDA product codes

CodeNameDevices
GESBlade, Scalpel678
GESBLADE, SCALPEL338
GDXScalpel, One-Piece178
EMFKNIFE, SURGICAL74
HRXArthroscope39
GFABlade, Saw, General & Plastic Surgery, Surgical26

GMDN & GCC registration

  • GMDN code 37445 · non‑implantable
  • Single‑use 95% · sterile 89% · Rx‑only 38% · OTC 4%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 9Weight (Gram) · 7Needle Gauge (Gauge) · 2Outer Diameter (Millimeter) · 1Angle (degree) · 1

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

How many manual scalpel blade, single-use products are registered in the US?

1,346 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual scalpel blade, single-use", from 68 companies. The largest labeler is Swann-Morton Limited with 13% of records.

Which FDA product codes apply?

GES (Blade, Scalpel), GES (BLADE, SCALPEL), GDX (Scalpel, One-Piece), 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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