Home GUDID 00841690102861 OMNI Mod Hip
Primary DI 00841690102861
Brand OMNI Mod Hip
Company Omni Life Science, Inc.
Model 151758
Catalog number 151758
Device description OMNI Modular Stem Size 8, 17.5mm
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 00841690102861 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 00841690102861 00841690102861 841690102861 0841690102861
GMDN Terms# Term, Definition table Term Definition Coated hip femur prosthesis, modular A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
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