Home GUDID 08800038034402 EZX
Primary DI 08800038034402
Brand EZX
Company IMEDICOM CO., LTD.
Model BRXLT50B
Published 2019-08-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 08800038034402 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800038034402 08800038034402 8800038034402
GMDN Terms# Term, Definition table Term Definition 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 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 the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 690340653 Device count 1 Premarket exempt true Lot or batch true Manufacturing 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 08800053401142 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401159 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401166 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401173 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401180 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401197 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401203 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401210 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401227 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401234 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401241 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401258 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401289 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401296 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401302 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401319 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401326 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401333 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401340 SharkCut Techcord co.,Ltd GFA 2024-04-15 08800053401265 SharkCut Techcord co.,Ltd GFA 2024-04-12 08800053401272 SharkCut Techcord co.,Ltd GFA 2024-04-12 07613327576566 PELLO STRYKER CORPORATION GFA 2023-09-13 07613327576672 PELLO STRYKER CORPORATION GFA 2023-09-13 07613327576696 PELLO STRYKER CORPORATION GFA 2023-09-13 07613327576719 PELLO STRYKER CORPORATION GFA 2023-09-13 07613327576733 PELLO STRYKER CORPORATION GFA 2023-09-13 07613327576740 PELLO STRYKER CORPORATION GFA 2023-09-13 07613327512342 CrossBlade STRYKER CORPORATION GFA 2021-06-21 07613327512311 CrossBlade STRYKER CORPORATION GFA 2020-11-09 07613327512328 CrossBlade STRYKER CORPORATION GFA 2020-11-09