Home GUDID 10885862086211 Equinoxe
Primary DI 10885862086211
Brand Equinoxe
Company Exactech, Inc.
Model 315-98-57
Catalog number 315-98-57
Device description INSTRUMENT KEEL DRILL GUIDE
Published 2022-07-28
Public version status Update
Distribution status Not 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 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 10885862086211 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10885862086211 10885862086211
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 157565946 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# 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 HSD 2026-09-22 03701037320440 FX V135 Shoulder Prosthesis FX SOLUTIONS KWT 2026-09-22 03701037321188 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FX SOLUTIONS HSD 2026-09-22 00840097533919 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097533926 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097533933 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097533940 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097533957 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097533964 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097533971 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097533988 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097533995 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097534008 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097534015 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 00840097534022 Veritas Hemiarthroplasty Restor3d, Inc. HSD 2026-09-18 B1132N2GI200050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI200050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI200100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI200100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI206000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 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 B1132N2GI208000 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI220050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18 B1132N2GI220050 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI220100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWS 2026-09-18 B1132N2GI220100 Shoulder Innovations InSet GO Shoulder Innovations, Inc. KWT 2026-09-18