Home GUDID 00889024707047 Signature ONE Software Package
Primary DI 00889024707047
Brand Signature ONE Software Package
Company Orthosoft Inc
Model 302.4018
Catalog number 302.4018
Published 2026-07-10
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 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 00889024707047 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 00889024707047 00889024707047 889024707047 0889024707047
GMDN Terms# Term, Definition table Term Definition Radiology DICOM image processing application software A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
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 true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840097533919 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533926 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533933 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533940 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533957 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533964 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533971 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533988 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097533995 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097534008 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097534015 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 00840097534022 Veritas Hemiarthroplasty Restor3d, Inc. PHX 2026-09-18 B1132N2GI200050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI200050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI200100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI200100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI206000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI206000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI208000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI208000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI220050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI220050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI220100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI220100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI226000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI226000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI228000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI228000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI240050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI240050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18