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Device Explorer · FDA GUDID · GMDN 43376

Surgical saw blade, sagittal, single-use

A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the

US‑registered devices3,439in commercial distribution
Companies24labelers on GUDID
Single‑use98%of device records
Sterile97%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Imedicom Co., Ltd.1,10932%
Gebr. Brasseler Gmbh & Co. Kg56216%
De Soutter Medical Limited55416%
Stryker Corporation54816%
Omega Surgical Instruments Inc2527%
Microaire Surgical Instruments Llc742%
Arthrex, Inc.712%
Conmed Corporation662%

Top labelers

CompanyDevicesShare
Imedicom Co., Ltd.1,10932%
Gebr. Brasseler Gmbh & Co. Kg56216%
De Soutter Medical Limited55416%
Stryker Corporation54816%
Omega Surgical Instruments Inc2527%
Microaire Surgical Instruments Llc742%
Arthrex, Inc.712%
Conmed Corporation662%
Smith & Nephew, Inc.552%
Aesculap Ag321%
Biomet Orthopedics, Llc150%
Treace Medical Concepts, Inc.150%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PELLONULLEZoutPrecision FalconStryker PrecisionNAStryker Performance SeriesSaw bladeDe Soutter MedicalNSK Sterile BladesSafedgeHiCUT Micro sawELAN 4Oscillating Saw BladeGENESIS IIDYONICS POWER

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

FDA product codes

CodeNameDevices
GFABlade, Saw, General & Plastic Surgery, Surgical1,694
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL880
GEYMotor, Surgical Instrument, Ac-Powered639
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces128
GESBlade, Scalpel95
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES62

GMDN & GCC registration

  • GMDN code 43376 · non‑implantable
  • Single‑use 98% · sterile 97% · 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

Depth (Millimeter) · 457Length (Millimeter) · 162Width (Millimeter) · 150Height (Millimeter) · 56Angle (degree) · 19Length (Centimeter) · 18

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

How many surgical saw blade, sagittal, single-use products are registered in the US?

3,439 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical saw blade, sagittal, single-use", from 24 companies. The largest labeler is Imedicom Co., Ltd. with 32% of records.

Which FDA product codes apply?

GFA (Blade, Saw, General & Plastic Surgery, Surgical), GFA (BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL), GEY (Motor, Surgical Instrument, Ac-Powered), HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Acces)

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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