Home GUDID 00846832087075 Tornier Perform Humeral System
Primary DI 00846832087075
Brand Tornier Perform Humeral System
Company TORNIER, INC.
Model IFX816S
Catalog number IFX816S
Device description Fracture Proximal Reamer
Published 2022-12-21
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 KWT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00846832087075 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 00846832087075 00846832087075 846832087075 0846832087075
GMDN Terms# Term, Definition table Term Definition Bone-resection orthopaedic reamer, reusable An orthopaedic surgical instrument intended to resect bone (cut out part of the bone) and precisely shape a specific area of bone to accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); some types may in addition be designed to be used endoscopically to resect hypertrophic tissue [e.g., ligamentum flavum] to relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 968990812 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00811596033460 CSR Shoulder System CATALYST ORTHOSCIENCE INC. KWT 2026-09-22 00811596033477 CSR Shoulder System CATALYST ORTHOSCIENCE INC. KWT 2026-09-22 00811596033484 CSR Shoulder System CATALYST ORTHOSCIENCE INC. KWT 2026-09-22 03701037320440 FX V135 Shoulder Prosthesis FX SOLUTIONS KWT 2026-09-22 B1132N2GI200050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI200100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI206000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI208000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 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 B1132N2GI226000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI228000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI240050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI240100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI246000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI248000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI270050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI270100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI276000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI278000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 00811596031961 CSR Shoulder System CATALYST ORTHOSCIENCE INC. KWT 2026-07-17 00811596031978 CSR Shoulder System CATALYST ORTHOSCIENCE INC. KWT 2026-07-17 00811596031985 CSR Shoulder System CATALYST ORTHOSCIENCE INC. KWT 2026-07-17 00889024707047 Signature ONE Software Package Orthosoft Inc KWT 2026-07-10 03701037315897 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FX SOLUTIONS KWT 2026-06-26 03701037315903 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FX SOLUTIONS KWT 2026-06-26 03701037315910 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FX SOLUTIONS KWT 2026-06-26 03701037315927 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FX SOLUTIONS KWT 2026-06-26 03701037315934 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FX SOLUTIONS KWT 2026-06-26 03701037315941 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FX SOLUTIONS KWT 2026-06-26