Home GUDID 10603295172444 S-ROM
Primary DI 10603295172444
Brand S-ROM
Company DEPUY ORTHOPAEDICS, INC.
Model 53-5332
Catalog number 535332
Device description S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 12 B FITS: 12 x 06 OR 12 x 07 STEM Cone: B
Published 2015-03-24
Public version status Update
Distribution status Not 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 KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate MRA Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic 2 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 MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic 2 MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10603295172444 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10603295172444 10603295172444
GMDN Terms# Term, Definition table Term Definition Sleeve femoral/tibial extension, coated A sterile implantable device typically designed to be attached to a revision femoral stem, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to make up for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included.
Regulatory Flags# DUNS number 080506581 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07611996118674 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142327 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142334 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142341 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142358 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142372 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142389 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142389 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142396 POLARSTEM Smith & Nephew, Inc. LZO 2016-09-01 07611996142396 POLARSTEM Smith & Nephew, Inc. MEH 2016-09-01 07611996074918 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074970 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075007 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075038 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095586 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095593 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095609 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095616 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095623 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095630 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095647 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095654 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19
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