Home GUDID 00817438020223 N/A
Primary DI 00817438020223
Brand N/A
Company Omega Surgical Instruments Inc
Model AGC-777R
Device description 90.0 MM X 15.0 MM X 1.31 MM OSCILLATING BLADE
Published 2022-06-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GFA Blade, Saw, General & Plastic Surgery, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817438020223 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00817438020223 00817438020223 817438020223 0817438020223
GMDN Terms# Term, Definition table Term Definition Surgical saw blade, oscillating, single-use A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and 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 sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 808825038 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00888867614956 Arthrex® ARTHREX, INC. GFA 2026-05-25 08404535025156 LARGE BONE BLADES Peter Brasseler Holdings, LLC GFA 2026-03-23 B504OM4515700130 DePuy Mitek Provision GFA 2026-03-19 B504OM50715940 Conmed Linvatec Provision GFA 2026-03-19 B504OMDC119090180 Conmed Linvatec Provision GFA 2026-03-19 00810111225366 Saw Blade Treace Medical Concepts, Inc. GFA 2026-01-26 00810111225342 Saw Blade Treace Medical Concepts, Inc. GFA 2026-01-07 00810111225335 Saw Blade Treace Medical Concepts, Inc. GFA 2025-12-18 08681506801180 SCHARF SCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETI GFA 2025-12-12 B39062901120331 Reprocessed 3mm Straight Shaver Blade SURETEK MEDICAL GFA 2025-12-09 B3906290112040121 Reprocessed 4mm Angled 12 Degree Shaver Blade SURETEK MEDICAL GFA 2025-12-09 B3906290112040601 Reprocessed 4mm Angled 60 Degree Shaver Blade SURETEK MEDICAL GFA 2025-12-09 16974940305963 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940305970 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940305987 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940305994 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306007 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306014 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306021 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306038 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 06974940306048 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 06974940306055 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306069 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306076 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306083 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306090 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306106 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306113 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306120 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05 16974940306137 endophix Suzhou Endophix Co., Ltd. GFA 2025-12-05
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