Home GUDID 00811596032647 F1x Fracture Stem System
Primary DI 00811596032647
Brand F1x Fracture Stem System
Company CATALYST ORTHOSCIENCE INC.
Model 1232-4005-007
Catalog number 1232-4005-007
Device description Splined Broach - 13
Published 2026-08-25
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 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 00811596032647 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 00811596032647 00811596032647 811596032647 0811596032647
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 00811596033460 CSR Shoulder System 1227-5120-001 1227-5120-001 2026-09-22 00811596033477 CSR Shoulder System 1227-5120-002 1227-5120-002 2026-09-22 00811596033484 CSR Shoulder System 1227-5120-003 1227-5120-003 2026-09-22 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 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
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