Home GUDID 00811596031992 EA Convertible System
Primary DI 00811596031992
Brand EA Convertible System
Company CATALYST ORTHOSCIENCE INC.
Model 1231-4605
Catalog number 1231-4605
Device description Humeral Head Removal Tool
Published 2026-07-17
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 HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented PHX Shoulder Prosthesis, Reverse Configuration
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic 2 KWS Prosthesis, Shoulder, Semi-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 00811596031992 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 00811596031992 00811596031992 811596031992 0811596031992
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning 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 [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, prostheses, or prosthesis components; 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 reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079702565 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 00811596031886 Reverse Shoulder System 1230-7523-001 1230-7523-001 2026-07-17 00811596031893 Reverse Shoulder System 1230-7523-002 1230-7523-002 2026-07-17 00811596031909 Reverse Shoulder System 1230-7524-001 1230-7524-001 2026-07-17 00811596031916 Reverse Shoulder System 1230-7524-002 1230-7524-002 2026-07-17 00811596031923 Reverse Shoulder System 1230-7513-003 1230-7513-003 2026-07-17 00811596031930 Reverse Shoulder System 1230-7514-003 1230-7514-003 2026-07-17 00811596031947 Reverse Shoulder System 1230-7525-001 1230-7525-001 2026-07-17 00811596031954 Reverse Shoulder System 1230-4313 1230-4313 2026-07-17 00811596031961 CSR Shoulder System 1226-5038-001 1226-5038-001 2026-07-17 00811596031978 CSR Shoulder System 1226-5038-002 1226-5038-002 2026-07-17 00811596031985 CSR Shoulder System 1226-5038-003 1226-5038-003 2026-07-17 00811596032005 Reverse Shoulder System 1230-4224-003 1230-4224-003 2026-07-17 00811596032012 Reverse Shoulder System 1230-4225-003 1230-4225-003 2026-07-17 00811596031695 EA Convertible System 1231-4601-001 1231-4601-001 2026-07-14 00811596031701 EA Convertible System 1231-4601-002 1231-4601-002 2026-07-14 00811596031718 EA Convertible System 1231-4601-003 1231-4601-003 2026-07-14 00811596031725 EA Convertible System 1231-4601-004 1231-4601-004 2026-07-14 00811596031732 EA Convertible System 1231-4601-005 231-4601-005 2026-07-14 00811596031749 EA Convertible System 1231-4601-006 1231-4601-006 2026-07-14 00811596031657 EA Convertible System 1231-4603-001 1231-4603-001 2026-07-13
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