Home GUDID 00811596031022 R1 Reverse Shoulder System
Primary DI 00811596031022
Brand R1 Reverse Shoulder System
Company CATALYST ORTHOSCIENCE INC.
Model 1230-4255
Device description Center Post Trephine
Published 2021-03-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name PHX Shoulder Prosthesis, Reverse Configuration
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PHX Shoulder Prosthesis, Reverse Configuration Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00811596031022 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 00811596031022 00811596031022 811596031022 0811596031022
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation instrument, reusable 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. It may be used for the following applications: 1) to hold/align/fix bone preparation 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 between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079702565 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00811596032524 F1x Fracture Stem System 1232-7551-001 1232-7551-001 2026-08-25 00811596032531 F1x Fracture Stem System 1232-7551-002 1232-7551-002 2026-08-25 00811596032548 F1x Fracture Stem System 1232-7551-003 1232-7551-003 2026-08-25 00811596032555 F1x Fracture Stem System 1232-7552-001 1232-7552-001 2026-08-25 00811596032562 F1x Fracture Stem System 1232-7552-002 1232-7552-002 2026-08-25 00811596032579 F1x Fracture Stem System 1232-7552-003 1232-7552-003 2026-08-25 00811596032586 F1x Fracture Stem System 1232-5003 1232-5003 2026-08-25 00811596032593 F1x Fracture Stem System 1232-4005-002 1232-4005-002 2026-08-25 00811596032609 F1x Fracture Stem System 1232-4005-003 1232-4005-003 2026-08-25 00811596032616 F1x Fracture Stem System 1232-4005-004 1232-4005-004 2026-08-25 00811596032623 F1x Fracture Stem System 1232-4005-005 1232-4005-005 2026-08-25 00811596032630 F1x Fracture Stem System 1232-4005-006 1232-4005-006 2026-08-25 00811596032647 F1x Fracture Stem System 1232-4005-007 1232-4005-007 2026-08-25 00811596032654 F1x Fracture Stem System 1232-4005-008 1232-4005-008 2026-08-25 00811596032661 F1x Fracture Stem System 1232-4005-009 1232-4005-009 2026-08-25 00811596032678 F1x Fracture Stem System 1232-4005-010 1232-4005-010 2026-08-25 00811596032685 F1x Fracture Stem System 1232-4005-011 1232-4005-011 2026-08-25 00811596032982 F1x Fracture Stem System 1232-4005-012 1232-4005-012 2026-08-25 00811596032036 Reverse Shoulder System 1230-5216 1230-5216 2026-08-18 00811596032050 Reverse Shoulder System 1230-7506-002 1230-7506-002 2026-08-18
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