Home GUDID 00810933031640 HIP BROACH HANDLE, GEN 2, NEUTRAL
Primary DI 00810933031640
Brand HIP BROACH HANDLE, GEN 2, NEUTRAL
Company Conformis, Inc.
Model 1080-696
Catalog number 1080-696
Device description HIP BROACH HANDLE, GEN 2, NEUTRAL
Published 2022-11-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810933031640 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 00810933031640 00810933031640 810933031640 0810933031640
GMDN Terms# Term, Definition table Term Definition Joint prosthesis implantation kit, reusable A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 808821883 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810933031114 Cordera Hip System Offset Cup Impactor, Enztec 1080-646 1080-646 2022-03-07 00810933031183 Cordera Hip System Radel Liner Impactors 28mm 1080-655 1080-655 2022-03-07 00810933031190 Cordera Hip System Radel Liner Impactors 32mm 1080-656 1080-656 2022-03-07 00810933031206 Cordera Hip System Radel Liner Impactors 36mm 1080-657 1080-657 2022-03-07 00810933031213 Cordera Hip System Radel Liner Impactors 40mm 1080-658 1080-658 2022-03-07 00810933031220 Cordera Hip System T-handle Quick Connect 1080-659 1080-659 2022-03-07 00810933031237 Cordera Hip System OrthoGroup Cup Impactor 1080-660 1080-660 2022-03-07 00850268007187 iTotal® Impactor Head 1080-541 2016-10-24 00850268007194 iTotal® Impactor Head 1080-535 2016-10-24 00850268007200 iTotal® CR Tibial Tray Impactor Tip 1080-536 2016-10-24 00850268007217 iTotal® PS Tibial Tray Impactor Tip 1080-542 2016-10-24 00850268007224 iTotal® Poly Impactor Tip 1080-524 2016-10-24 M572HDL060C24S011 iTotal® Hip Replacement System HDL060C24S01 HDL060C24S 2018-08-06 M572HDL060D24S011 iTotal® Hip Replacement System HDL060D24S01 HDL060D24S 2018-07-30 M572HDL060D34S011 iTotal® Hip Replacement System HDL060D34S01 HDL060D34S 2018-08-06 M572HDL060E24S011 iTotal® Hip Replacement System HDL060E24S01 HDL060E24S 2018-08-06 M572HDL060E34S011 iTotal® Hip Replacement System HDL060E34S01 HDL060E34S 2018-08-06 M572HDL060F24S011 iTotal® Hip Replacement System HDL060F24S01 HDL060F24S 2018-08-06 M572HDL060F34S011 iTotal® Hip Replacement System HDL060F34S01 HDL060F34S 2018-08-06 M572HDL060C10S011 iTotal® Hip Replacement System HDL060C10S01 HDL060C10S 2018-08-06
Other Devices Sharing Product Codes# 
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