Home GUDID 00887868557606 PSI Knee
Primary DI 00887868557606
Brand PSI Knee
Company Orthosoft Inc
Model 803.302
Catalog number 803.302
Published 2022-08-11
Public version status Update
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 JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer OOG Knee Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2 MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic 2 OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00887868557606 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 00887868557606 00887868557606 887868557606 0887868557606
GMDN Terms# Term, Definition table Term Definition Orthopaedic surgical planning radiology software A software program intended to display and analyse/process images of a limb bone(s), rib(s), the sternum and/or pelvis (excludes craniofacial and spinal), primarily to assist with the planning of an orthopaedic surgical procedure (typically manual or robotic-assisted arthroplasty). The images are typically acquired via x-ray [e.g., computed tomography (CT)]. It may include a library of three-dimensional (3D) implants intended to facilitate planning. It does not incorporate adaptive/dynamic machine learning (ML) models.
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 false 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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