Home GUDID 00841690100072 OMNI K1 Hip
Primary DI 00841690100072
Brand OMNI K1 Hip
Company Omni Life Science, Inc.
Model HC-00040
Catalog number HC-00040
Device description K1 Femoral Stem, Size 4
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841690100072 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 00841690100072 00841690100072 841690100072 0841690100072
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 07611996098075 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098082 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098099 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098105 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098112 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098129 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098136 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098143 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098150 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098174 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098501 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098518 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098525 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996098532 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111323 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111330 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111354 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111378 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111392 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111408 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111415 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111422 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111446 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111514 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111538 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996111552 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996112320 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996112351 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996112368 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25 07611996114638 POLARCUP Smith & Nephew, Inc. LPH 2015-11-25
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