Home GUDID 10885862083593 Equinoxe
Primary DI 10885862083593
Brand Equinoxe
Company Exactech, Inc.
Model 305-21-00
Catalog number 305-21-00
Device description FRACTURE STEM POSITIONING DEVICE
Published 2022-07-28
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 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 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 10885862083593 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10885862083593 10885862083593
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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 157565946 Device count 1 Lot or batch 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 00889024707047 Signature ONE Software Package Orthosoft Inc KWS 2026-07-10 00889024707047 Signature ONE Software Package Orthosoft Inc KWT 2026-07-10 00887868554391 Signature™ Comprehensive® Orthosoft Inc KWS 2024-02-09 00887868554391 Signature™ Comprehensive® Orthosoft Inc KWT 2024-02-09 00887868554407 Signature™ Comprehensive® Orthosoft Inc KWS 2024-02-09 00887868554407 Signature™ Comprehensive® Orthosoft Inc KWT 2024-02-09 00885556810613 AETOS Shoulder System Smith & Nephew, Inc. KWS 2023-02-13 00885556810613 AETOS Shoulder System Smith & Nephew, Inc. KWT 2023-02-13 00885556810057 AETOS Shoulder System Smith & Nephew, Inc. KWS 2023-02-08 00885556810057 AETOS Shoulder System Smith & Nephew, Inc. KWT 2023-02-08 00885556810064 AETOS Shoulder System Smith & Nephew, Inc. KWT 2023-02-08 00885556810064 AETOS Shoulder System Smith & Nephew, Inc. KWS 2023-02-08 00885556810071 AETOS Shoulder System Smith & Nephew, Inc. KWS 2023-02-08 00885556810071 AETOS Shoulder System Smith & Nephew, Inc. KWT 2023-02-08 00885556810125 AETOS Shoulder System Smith & Nephew, Inc. KWS 2023-02-08 00885556810125 AETOS Shoulder System Smith & Nephew, Inc. KWT 2023-02-08 00885556810132 AETOS Shoulder System Smith & Nephew, Inc. KWS 2023-02-08 00885556810132 AETOS Shoulder System Smith & Nephew, Inc. KWT 2023-02-08 00885556810149 AETOS Shoulder System Smith & Nephew, Inc. KWS 2023-02-08