Home GUDID 00841690119609 OMNI Hip
Primary DI 00841690119609
Brand OMNI Hip
Company Omni Life Science, Inc.
Model H3-82858
Catalog number H3-82858
Device description Bipolar Head, 58mm OD, 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 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 00841690119609 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 00841690119609 00841690119609 841690119609 0841690119609
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.
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. KWY 2017-01-12 07611996142327 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142334 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142341 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142358 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142372 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142389 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996074901 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074918 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074925 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074956 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074987 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095586 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095593 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095616 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095630 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095647 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095678 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095685 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996103410 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103427 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103441 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103458 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25
omnils.com