Home GUDID 00810933030537 ITOTAL IDENTITY TIBIAL CUT GUIDE SMALL RIGHT
Primary DI 00810933030537
Brand ITOTAL IDENTITY TIBIAL CUT GUIDE SMALL RIGHT
Company Conformis, Inc.
Model 1080-226
Published 2019-09-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name OOG Knee Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810933030537 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 00810933030537 00810933030537 810933030537 0810933030537
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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M572TCR000D00F021 Identity Imprint CR Knee Replacement System TCR-000-D00F1 TCR-000-D00F 2024-06-26 M572TCR000D00T021 Identity Imprint CR Knee Replacement System TCR-000-D00T1 TCR-000-D00T 2024-06-26 M572TPS000D00F021 Identity Imprint PS Knee Replacement System TPS-000-D00F1 TPS-000-D00F 2024-06-26 M572TCR302T07S011 Identity Imprint Porous CR TCR-302-T07S-01 TCR-302-T07S 2024-01-24 00810933031817 Calcar Planer Adapter Drop-in 1080-700 1080-700 2023-12-05 M572POV0123208011 Identity Imprint Porous CR POV-012-3208-01 POV-012-3208 2023-09-08 M572POV0123509011 Identity Imprint Porous CR POV-012-3509-01 POV-012-3509 2023-09-08 M572POV0123809011 Identity Imprint Porous CR POV-012-3809-01 POV-012-3809 2023-09-08 M572POV0124110011 Identity Imprint Porous CR POV-012-4110-01 POV-012-4110 2023-09-08 M572POV0124411011 Identity Imprint Porous CR POV-012-4411-01 POV-012-4411 2023-09-08 M572TCR102F01S011 Identity Imprint Porous CR TCR-102-F01S-01 TCR-102-F01S 2023-09-08 M572TCR102F02N011 Identity Imprint Porous CR TCR-102-F02N-01 TCR-102-F02N 2023-09-08 M572TCR102F02S011 Identity Imprint Porous CR TCR-102-F02S-01 TCR-102-F02S 2023-09-08 M572TCR102F03N011 Identity Imprint Porous CR TCR-102-F03N-01 TCR-102-F03N 2023-09-08 M572TCR102F03S011 Identity Imprint Porous CR TCR-102-F03S-01 TCR-102-F03S 2023-09-08 M572TCR102F04N011 Identity Imprint Porous CR TCR-102-F04N-01 TCR-102-F04N 2023-09-08 M572TCR102F04S011 Identity Imprint Porous CR TCR-102-F04S-01 TCR-102-F04S 2023-09-08 M572TCR102F05N011 Identity Imprint Porous CR TCR-102-F05N-01 TCR-102-F05N 2023-09-08 M572TCR102F05S011 Identity Imprint Porous CR TCR-102-F05S-01 TCR-102-F05S 2023-09-08 M572TCR102F06N011 Identity Imprint Porous CR TCR-102-F06N-01 TCR-102-F06N 2023-09-08
Other Devices Sharing Product Codes# 
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