Home GUDID 00810933030506 ITOTAL IDENTITY FEMORAL CUT GUIDE SMALL
Primary DI 00810933030506
Brand ITOTAL IDENTITY FEMORAL CUT GUIDE SMALL
Company Conformis, Inc.
Model 1080-223
Published 2019-09-27
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 OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OOG Knee Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic 2 OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810933030506 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 00810933030506 00810933030506 810933030506 0810933030506
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 808821883 Device count 1 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07630030891595 My Knee Femoral Cutting Blocks Medacta International SA OOG 2023-09-13 07630030868047 My Knee Medacta International SA OOG 2021-07-05 07630030868023 My Knee Femoral Cutting Blocks Medacta International SA OOG 2021-06-25 08800068942272 EXULT Knee Replacement System Corentec Co., Ltd OOG 2020-08-17 08800068942289 EXULT Knee Replacement System Corentec Co., Ltd OOG 2020-08-17 08800068942296 EXULT Knee Replacement System Corentec Co., Ltd OOG 2020-08-17 08800068942302 EXULT Knee Replacement System Corentec Co., Ltd OOG 2020-08-17 08800068942319 EXULT Knee Replacement System Corentec Co., Ltd OOG 2020-08-17 08428898831216 BIOMET KNEE SYSTEM Biomet Orthopedics, LLC OIY 2015-10-24 08428898831230 BIOMET KNEE SYSTEM Biomet Orthopedics, LLC OIY 2015-10-24 08428898831209 BIOMET KNEE SYSTEM Biomet Orthopedics, LLC OIY 2015-10-24 08428898831223 BIOMET KNEE SYSTEM Biomet Orthopedics, LLC OIY 2015-10-24 07630030847868 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030847875 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030847905 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030847912 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030847943 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030847950 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030847981 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030847998 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848025 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848032 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848063 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848070 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848100 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848117 My Knee Femoral Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848131 My Knee Tibial Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848162 My Knee Tibial Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848179 My Knee Tibial Cutting Blocks Medacta International SA OOG 2014-11-18 07630030848209 My Knee Tibial Cutting Blocks Medacta International SA OOG 2014-11-18
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