Home GUDID 07613327208832 INSTRUMENT
Primary DI 07613327208832
Brand INSTRUMENT
Company Howmedica Osteonics Corp.
Model 1100-1225
Catalog number 1100-1225
Device description CUTTING EDGE ADVANTAGE TRIAL NECK
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HWC Screw, fixation, bone JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented KWL Prosthesis, hip, hemi-, femoral, metal KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWC Screw, Fixation, Bone Orthopedic 2 JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic 2 KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic 2 KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic 2 KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic 2 LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic 2 LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic 2 LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic 2 MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic 2 MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic 2 MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07613327208832 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07613327208832 07613327208832 7613327208832
GMDN Terms# Term, Definition table Term Definition Femoral stem prosthesis trial A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 058311945 Device count 1 DM exempt true Premarket exempt true 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#