Home GUDID 00889024304147 PSI Shoulder
Primary DI 00889024304147
Brand PSI Shoulder
Company Orthosoft Inc
Model 20-8075-005-00
Published 2017-09-12
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
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 PHX Shoulder Prosthesis, Reverse Configuration
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 PHX Shoulder Prosthesis, Reverse Configuration Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00889024304147 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 00889024304147 00889024304147 889024304147 0889024304147
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 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 00889024707047 Signature ONE Software Package 302.4018 302.4018 2026-07-10 00889024699762 ROSA® Shoulder 20-8087-142-00 20-8087-142-00 2026-06-26 00889024699779 ROSA® Shoulder 20-8087-141-00 20-8087-141-00 2026-06-26 00889024699786 ROSA® Shoulder 20-8087-150-01 20-8087-150-01 2026-06-26 00889024699793 ROSA® Shoulder 20-8087-151-00 20-8087-151-00 2026-06-26 00889024699809 ROSA® Shoulder 20-8087-150-02 20-8087-150-02 2026-06-26 00889024699816 ROSA® Shoulder 20-8087-150-03 20-8087-150-03 2026-06-26 00889024699823 ROSA® Shoulder 20-8087-140-00 20-8087-140-00 2026-06-26 00887868552120 ROSA® 20-8020-158-00 20-8020-158-00 2023-04-10 00887868552137 ROSA® 20-8020-159-00 20-8020-159-00 2023-04-10 00887868552144 ROSA® 20-8020-160-00 20-8020-160-00 2023-04-10 00889024687455 ROSA® Knee 20-8020-130-01 2025-11-21 00887868581083 ROSA® Robotics 20-8020-013-00 20-8020-013-00 2026-02-20 00889024703186 ROSA® Shoulder 20-8087-700-00 20-8087-700-00 2026-01-27 00889024674790 ROSA PIN STABILIZER 60MM 20-8020-039-00 20-8020-039-00 2025-12-12 00889024674776 ROSA POLYAXIAL REFERENCE SIZE 3 20-8020-037-00 20-8020-037-00 2025-12-11 00889024674783 ROSA POLYAXIAL REFERENCE SIZE 6 20-8020-038-00 20-8020-038-00 2025-12-11 00889024674806 ROSA STABILIZER TISSUE DEFLECTOR 60MM 20-8020-040-00 20-8020-040-00 2025-12-11 00887868557873 ROSA® Shoulder 20-8087-100-01 20808710001 2024-03-06 00887868557880 ROSA® Shoulder 20-8087-100-02 20808710002 2024-03-06
Other Devices Sharing Product Codes# 
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