Home GUDID 04547898305818 Initia Total Hip System
Primary DI 04547898305818
Brand Initia Total Hip System
Company KYOCERA CORPORATION
Model GMH02-100043
Catalog number GMH02-100043
Device description INITIA SHELL 52-NH
Published 2017-02-21
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 04547898305818 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04547898305818 04547898305818 4547898305818
GMDN Terms# Term, Definition table Term Definition Metal-on-polyethylene total hip prosthesis A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 690557624 Device count 1 Serial number true Expiration date on label 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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