Home GUDID 00816127022852 iNSitu™ Hip System
Primary DI 00816127022852
Brand iNSitu™ Hip System
Company NEXTSTEP ARTHROPEDIX, LLC
Model 10-41-3652
Device description Acetabular Liner, Size 52 x 36mm ID, Hooded
Published 2023-09-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use 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 00816127022852 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 00816127022852 00816127022852 816127022852 0816127022852
GMDN Terms# Term, Definition table Term Definition Non-constrained polyethylene acetabular liner A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.
Regulatory Flags# DUNS number 060211165 Device count 1 DM exempt true Lot or batch true Manufacturing date on label true Expiration date on label 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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