Home GUDID 10885862622655 Equinoxe
Primary DI 10885862622655
Brand Equinoxe
Company Exactech, Inc.
Model SPI-046719
Catalog number SPI-046719
Device description Ergo Angle Reamer Driver
Published 2023-09-05
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 HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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 KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10885862622655 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10885862622655 10885862622655
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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 157565946 Device count 1 Lot or batch true Serial number 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 07630542795602 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795817 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795824 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795831 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795848 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795855 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 07630542795879 Anatomic Shoulder Prosthesis Medacta International SA KWS 2026-09-28 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 03701037320440 FX V135 Shoulder Prosthesis FX SOLUTIONS HSD 2026-09-22 03701037321188 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FX SOLUTIONS HSD 2026-09-22 00889024707047 Signature ONE Software Package Orthosoft Inc HSD 2026-07-10 00889024707047 Signature ONE Software Package Orthosoft Inc KWT 2026-07-10 00889024707047 Signature ONE Software Package Orthosoft Inc KWS 2026-07-10 00887868554391 Signature™ Comprehensive® Orthosoft Inc KWS 2024-02-09 00887868554391 Signature™ Comprehensive® Orthosoft Inc KWT 2024-02-09 00887868554391 Signature™ Comprehensive® Orthosoft Inc HSD 2024-02-09 00887868554407 Signature™ Comprehensive® Orthosoft Inc KWS 2024-02-09 00887868554407 Signature™ Comprehensive® Orthosoft Inc KWT 2024-02-09 00887868554407 Signature™ Comprehensive® Orthosoft Inc HSD 2024-02-09 00885556810613 AETOS Shoulder System Smith & Nephew, Inc. KWT 2023-02-13 00885556810613 AETOS Shoulder System Smith & Nephew, Inc. HSD 2023-02-13 00885556810613 AETOS Shoulder System Smith & Nephew, Inc. KWS 2023-02-13 00885556810057 AETOS Shoulder System Smith & Nephew, Inc. KWT 2023-02-08 00885556810057 AETOS Shoulder System Smith & Nephew, Inc. KWS 2023-02-08 00885556810057 AETOS Shoulder System Smith & Nephew, Inc. HSD 2023-02-08 00885556810064 AETOS Shoulder System Smith & Nephew, Inc. KWT 2023-02-08 00885556810064 AETOS Shoulder System Smith & Nephew, Inc. HSD 2023-02-08