Home GUDID 00816127023248 iNSitu™ Hip System
Primary DI 00816127023248
Brand iNSitu™ Hip System
Company NEXTSTEP ARTHROPEDIX, LLC
Model 10-95-3014
Device description Diamond Blade Calcar Planer
Published 2023-09-01
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 LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic 2 LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic 2 OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic 2 OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816127023248 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 00816127023248 00816127023248 816127023248 0816127023248
GMDN Terms# Term, Definition table Term Definition Bone-resection orthopaedic reamer, reusable An orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 060211165 Device count 1 DM exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816127025518 TheRay Collared and Collarless Femoral Stem 12-12-0000 2025-09-02 00816127025525 TheRay Collared and Collarless Femoral Stem 12-12-0001 2025-09-02 00816127025532 TheRay Collared and Collarless Femoral Stem 12-12-0002 2025-09-02 00816127025549 TheRay Collared and Collarless Femoral Stem 12-12-0003 2025-09-02 00816127025556 TheRay Collared and Collarless Femoral Stem 12-12-0004 2025-09-02 00816127025563 TheRay Collared and Collarless Femoral Stem 12-12-0005 2025-09-02 00816127025570 TheRay Collared and Collarless Femoral Stem 12-12-0006 2025-09-02 00816127025587 TheRay Collared and Collarless Femoral Stem 12-12-0007 2025-09-02 00816127025594 TheRay Collared and Collarless Femoral Stem 12-12-0008 2025-09-02 00816127025600 TheRay Collared and Collarless Femoral Stem 12-12-0009 2025-09-02 00816127025617 TheRay Collared and Collarless Femoral Stem 12-12-0010 2025-09-02 00816127025648 TheRay Collared and Collarless Femoral Stem 12-13-0000 2025-09-02 00816127025655 TheRay Collared and Collarless Femoral Stem 12-13-0001 2025-09-02 00816127025662 TheRay Collared and Collarless Femoral Stem 12-13-0002 2025-09-02 00816127025679 TheRay Collared and Collarless Femoral Stem 12-13-0003 2025-09-02 00816127025686 TheRay Collared and Collarless Femoral Stem 12-13-0004 2025-09-02 00816127025693 TheRay Collared and Collarless Femoral Stem 12-13-0005 2025-09-02 00816127025709 TheRay Collared and Collarless Femoral Stem 12-13-0006 2025-09-02 00816127025716 TheRay Collared and Collarless Femoral Stem 12-13-0007 2025-09-02 00816127025723 TheRay Collared and Collarless Femoral Stem 12-13-0008 2025-09-02
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