Home GUDID B1132L2HB000020 Shoulder Innovations InSet 135 Instrument Case/Tray
Primary DI B1132L2HB000020
Brand Shoulder Innovations InSet 135 Instrument Case/Tray
Company Shoulder Innovations, Inc.
Model InSet 135 Instrument Case/Tray
Catalog number 2L2HB00002
Device description Shoulder Innovations - InSet 135 Instrument Case/Tray
Published 2025-12-12
Public version status New
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 MBX Stimulator, Thalamic, Epilepsy, Implanted PHX Shoulder Prosthesis, Reverse Configuration
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 MBX Stimulator, Thalamic, Epilepsy, Implanted Unknown 3 PHX Shoulder Prosthesis, Reverse Configuration Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B1132L2HB000020 Primary HIBCC 0
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 080404519 Device count 1 Lot or batch true Serial number true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B1132R2HC300100 Shoulder Innovations RSA Glenosphere Trial Instrument Case RSA Glenosphere Trial Instrument Case 2R2HC30010 2026-09-30 B1132N2GI200050 Shoulder Innovations InSet GO 20 mm x 5° 2N2GI20005 2026-09-18 B1132N2GI200100 Shoulder Innovations InSet GO 20 mm x 10° 2N2GI20010 2026-09-18 B1132N2GI206000 Shoulder Innovations InSet GO 20 mm x 6mm 2N2GI20600 2026-09-18 B1132N2GI208000 Shoulder Innovations InSet GO 20 mm x 8mm 2N2GI20800 2026-09-18 B1132N2GI220050 Shoulder Innovations InSet GO 22 mm x 5° 2N2GI22005 2026-09-18 B1132N2GI220100 Shoulder Innovations InSet GO 22 mm x 10° 2N2GI22010 2026-09-18 B1132N2GI226000 Shoulder Innovations InSet GO 22 mm x 6mm 2N2GI22600 2026-09-18 B1132N2GI228000 Shoulder Innovations InSet GO 22 mm x 8mm 2N2GI22800 2026-09-18 B1132N2GI240050 Shoulder Innovations InSet GO 24 mm x 5° 2N2GI24005 2026-09-18 B1132N2GI240100 Shoulder Innovations InSet GO 24 mm x 10° 2N2GI24010 2026-09-18 B1132N2GI246000 Shoulder Innovations InSet GO 24 mm x 6mm 2N2GI24600 2026-09-18 B1132N2GI248000 Shoulder Innovations InSet GO 24 mm x 8mm 2N2GI24800 2026-09-18 B1132N2GI270050 Shoulder Innovations InSet GO 27 mm x 5° 2N2GI27005 2026-09-18 B1132N2GI270100 Shoulder Innovations InSet GO 27 mm x 10° 2N2GI27010 2026-09-18 B1132N2GI276000 Shoulder Innovations InSet GO 27 mm x 6mm 2N2GI27600 2026-09-18 B1132N2GI278000 Shoulder Innovations InSet GO 27 mm x 8mm 2N2GI27800 2026-09-18 B1132A2HI000100 Shoulder Innovations InSet 95 Humeral Stem Low Profile Lever Lock Broach Handle 2A2HI00010 2026-05-28 B1130S1GK000030 Shoulder Innovations InSet 70 Humeral Stem K-Wire, 2.4mm x 90mm 0S1GK00003 2025-09-18 B1130S1GK000020 Shoulder Innovations Humeral Short Stem System K-Wire Guide 0S1GK00002 2023-11-28
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