Home GUDID 00889024304154 Bigliani/Flatow
Primary DI 00889024304154
Brand Bigliani/Flatow
Company Orthosoft Inc
Model 20-8075-007-01
Catalog number 20-8075-007-01
Published 2016-09-12
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 00889024304154 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 00889024304154 00889024304154 889024304154 0889024304154
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant aiming arm A surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable 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 true 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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