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Device Explorer · FDA GUDID · GMDN 45493

Surgical saw blade, reciprocating, single-use

A sterile, 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 thr

US‑registered devices947in commercial distribution
Companies21labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Imedicom Co., Ltd.30032%
Zimmer Orthopaedic Surgical Products, Inc.14816%
Bien-Air Surgery Sa11612%
Gebr. Brasseler Gmbh & Co. Kg808%
De Soutter Medical Limited667%
Omega Surgical Instruments Inc586%
Peter Brasseler Holdings, Llc505%
Aesculap Ag283%

Top labelers

CompanyDevicesShare
Imedicom Co., Ltd.30032%
Zimmer Orthopaedic Surgical Products, Inc.14816%
Bien-Air Surgery Sa11612%
Gebr. Brasseler Gmbh & Co. Kg808%
De Soutter Medical Limited667%
Omega Surgical Instruments Inc586%
Peter Brasseler Holdings, Llc505%
Aesculap Ag283%
Conmed Corporation253%
Microaire Surgical Instruments Llc192%
Synvasive Technology, Inc.152%
Nakanishi Inc.91%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NULLN/ADe Soutter MedicalNSK Sterile BladesHiCUT Micro sawELAN 4Reciprocating saw bladeAPEX 3D Total Ankle Replacement SystemOxford Surgical BladesStablecut® Vanguard™Stablecut®Arthrex®Brasseler USANON-BR2000 LARGE BONE BLADESSMALL BONE BLADESNA

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, Surgical546
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL497
GEYMotor, Surgical Instrument, Ac-Powered76
GESBlade, Scalpel38
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)19
HBCMOTOR, DRILL, ELECTRIC18

GMDN & GCC registration

  • GMDN code 45493 · non‑implantable
  • Single‑use 99% · sterile 99% · Rx‑only 68% · 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) · 108Width (Millimeter) · 104Height (Millimeter) · 18

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

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

947 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical saw blade, reciprocating, single-use", from 21 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), GES (Blade, Scalpel)

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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