Home GUDID 00844588011092 Consensus® Hip System
Primary DI 00844588011092
Brand Consensus® Hip System
Company CONSENSUS ORTHOPEDICS, INC.
Model 1020-0-4243
Catalog number 1020-0-4243
Device description Bipolar Assembly
Published 2015-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00844588011092 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 00844588011092 00844588011092 844588011092 0844588011092
GMDN Terms# Term, Definition table Term Definition Femoral head bipolar component A sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 22 Millimeter
Regulatory Flags# DUNS number 824905723 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product true Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00844588044311 TracPatch 4000-0-1000 4000-0-1000 2020-03-26 00844588006111 Consensus® Knee System 2151-0-0001 2151-0-0001 2015-10-05 00844588006128 Consensus® Knee System 2151-0-0002 2151-0-0002 2015-10-05 00844588006135 Consensus® Knee System 2151-0-0003 2151-0-0003 2015-10-05 00844588006142 Consensus® Knee System 2151-0-0004 2151-0-0004 2015-10-05 00844588006159 Consensus® Knee System 2151-0-0005 2151-0-0005 2015-10-05 00844588006166 Consensus® Knee System 2151-0-0006 2151-0-0006 2015-10-05 00844588006173 Consensus® Knee System 2152-0-0001 2152-0-0001 2015-10-05 00844588006180 Consensus® Knee System 2152-0-0002 2152-0-0002 2015-10-05 00844588006197 Consensus® Knee System 2152-0-0003 2152-0-0003 2015-10-05 00844588006203 Consensus® Knee System 2152-0-0004 2152-0-0004 2015-10-05 00844588006210 Consensus® Knee System 2152-0-0005 2152-0-0005 2015-10-05 00844588006227 Consensus® Knee System 2152-0-0006 2152-0-0006 2015-10-05 00844588006234 Consensus® Knee System 2153-0-0001 2153-0-0001 2015-10-05 00844588006241 Consensus® Knee System 2153-0-0002 2153-0-0002 2015-10-05 00844588006258 Consensus® Knee System 2153-0-0003 2153-0-0003 2015-10-05 00844588006265 Consensus® Knee System 2153-0-0004 2153-0-0004 2015-10-05 00844588006272 Consensus® Knee System 2153-0-0005 2153-0-0005 2015-10-05 00844588006289 Consensus® Knee System 2153-0-0006 2153-0-0006 2015-10-05 00844588006296 Consensus® Knee System 2154-0-0001 2154-0-0001 2015-10-05
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