Home GUDID 00841690119913 OMNI Interface Acetabular System
Primary DI 00841690119913
Brand OMNI Interface Acetabular System
Company Omni Life Science, Inc.
Model H5-45228
Catalog number H5-45228
Device description ApeX-LNK Acetabular Insert, UHMWPE 0 degree Hood, F Insert/28mm ID
Published 2015-11-27
Public version status Update
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 MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
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 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 00841690119913 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 00841690119913 00841690119913 841690119913 0841690119913
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.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 061339651 Device count 1 DM exempt true Lot or batch true Expiration date on label true Sterilization required before use 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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