Home GUDID 00887868554391 Signature™ Comprehensive®
Primary DI 00887868554391
Brand Signature™ Comprehensive®
Company Orthosoft Inc
Model 20-8090-009-01
Catalog number 20-8090-009-01
Published 2024-02-09
Public version status New
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 HSD PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED 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 HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic 2 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 00887868554391 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 00887868554391 00887868554391 887868554391 0887868554391
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning 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 [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other 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 (non-adaptive) 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 Expiration 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 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. HSD 2026-07-17 00811596031886 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031893 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. HSD 2026-07-17 00811596031893 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031909 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. HSD 2026-07-17 00811596031909 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031916 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. HSD 2026-07-17 00811596031916 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031923 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. HSD 2026-07-17 00811596031923 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031930 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. HSD 2026-07-17 00811596031930 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031947 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. HSD 2026-07-17 00811596031947 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. PHX 2026-07-17 00811596031954 Reverse Shoulder System CATALYST ORTHOSCIENCE INC. HSD 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
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