Home GUDID 00887868522994 Signature ONE
Primary DI 00887868522994
Brand Signature ONE
Company Orthosoft Inc
Model 20-8090-008-02
Device description Alliance Glenoid Shoulder Guide and Bone Model Right
Published 2022-07-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented PHX Shoulder Prosthesis, Reverse Configuration QHE Shoulder Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic 2 KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic 2 MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic 2 PHX Shoulder Prosthesis, Reverse Configuration Orthopedic 2 QHE Shoulder Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00887868522994 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 00887868522994 00887868522994 887868522994 0887868522994
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation instrument, single-use 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 single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 205670032 Device count 1 Kit true Lot or batch 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 00840097513119 Veritas Reverse Total Shoulder Restor3d, Inc. PHX 2026-07-24 00840097513119 Veritas Reverse Total Shoulder Restor3d, Inc. QHE 2026-07-24 00840097513126 Veritas Reverse Total Shoulder Restor3d, Inc. QHE 2026-07-24 00840097513126 Veritas Reverse Total Shoulder Restor3d, Inc. PHX 2026-07-24 00840097513133 Veritas Reverse Total Shoulder Restor3d, Inc. QHE 2026-07-24 00840097513133 Veritas Reverse Total Shoulder Restor3d, Inc. PHX 2026-07-24 00840097516004 Veritas Reverse Total Shoulder Restor3d, Inc. QHE 2026-07-24 00840097516004 Veritas Reverse Total Shoulder Restor3d, Inc. PHX 2026-07-24 00840097516011 Veritas Reverse Total Shoulder Restor3d, Inc. QHE 2026-07-24 00840097516011 Veritas Reverse Total Shoulder Restor3d, Inc. PHX 2026-07-24 00811596031886 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031893 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031909 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031916 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031923 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031930 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031947 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031954 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031961 CSR Shoulder System CATALYST ORTHOSCIENCE INC. KWT 2026-07-17 00811596031978 CSR Shoulder System CATALYST ORTHOSCIENCE INC. KWT 2026-07-17 00811596031985 CSR Shoulder System CATALYST ORTHOSCIENCE INC. KWT 2026-07-17 00811596031992 EA Convertible System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031992 EA Convertible System CATALYST ORTHOSCIENCE INC. KWS 2026-07-17 00811596032005 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596032012 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 05404028001288 SurgiCase Planner Materialise NV QHE 2026-07-16 05404028001288 SurgiCase Planner Materialise NV KWS 2026-07-16 05404028001288 SurgiCase Planner Materialise NV PHX 2026-07-16 00811596031695 EA Convertible System CATALYST ORTHOSCIENCE INC. PHX 2026-07-14 00811596031695 EA Convertible System CATALYST ORTHOSCIENCE INC. KWS 2026-07-14
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