Home GUDID 00841690119302 OMNI Hip
Primary DI 00841690119302
Brand OMNI Hip
Company Omni Life Science, Inc.
Model H3-53699
Catalog number H3-53699
Device description Biolox Delta Femoral Head 36 mm -4mm
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 LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841690119302 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 00841690119302 00841690119302 841690119302 0841690119302
GMDN Terms# Term, Definition table Term Definition Ceramic femoral head prosthesis A sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
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 07611996142341 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142358 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142389 POLARSTEM Smith & Nephew, Inc. LZO 2017-01-12 07611996142396 POLARSTEM Smith & Nephew, Inc. LZO 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 07611996095661 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095678 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095685 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996103410 POLARSTEM Smith & Nephew, Inc. LZO 2016-07-25 07611996103427 POLARSTEM Smith & Nephew, Inc. LZO 2016-07-25
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