Initia Total Hip System GMH02-100008

GUDID 04547898305467

INITIA SHELL 54-7H

KYOCERA CORPORATION

Metal-on-polyethylene total hip prosthesis
Primary Device ID04547898305467
NIH Device Record Keyc2a8f7a4-e7ae-4302-93e2-b8f31cec88e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameInitia Total Hip System
Version Model NumberGMH02-100008
Catalog NumberGMH02-100008
Company DUNS694697025
Company NameKYOCERA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS104547898305467 [Primary]

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-03-18
Device Publish Date2017-02-21

On-Brand Devices [Initia Total Hip System]

04547898737541STD-HO LINER TRIAL 28-44
04547898737534STD-HO LINER TRIAL 40-72/74
04547898737527STD-HO LINER TRIAL 36-72/74
04547898737510STD-HO LINER TRIAL 32-72/74
04547898737503STD-HO LINER TRIAL 40-66/68/70
04547898737497STD-HO LINER TRIAL 36-66/68/70
04547898737480STD-HO LINER TRIAL 32-66/68/70
04547898737473STD-HO LINER TRIAL 40-60/62/64
04547898737466STD-HO LINER TRIAL 36-60/62/64
04547898737459STD-HO LINER TRIAL 32-60/62/64
04547898737442STD-HO LINER TRIAL 40-56/58
04547898737435STD-HO LINER TRIAL 36-56/58
04547898737428STD-HO LINER TRIAL 32-56/58
04547898737411STD-HO LINER TRIAL 36-52/54
04547898737404STD-HO LINER TRIAL 32-52/54
04547898737398STD-HO LINER TRIAL 36-50
04547898737381STD-HO LINER TRIAL 32-50
04547898737374STD-HO LINER TRIAL 28-50
04547898737367STD-HO LINER TRIAL 32-48
04547898737350STD-HO LINER TRIAL 28-48
04547898737343STD-HO LINER TRIAL 32-46
04547898737336STD-HO LINER TRIAL 28-46
04547898737312STD LINER TRIAL 28-44
04547898737305STD LINER TRIAL 40-72/74
04547898737299STD LINER TRIAL 36-72/74
04547898737282STD LINER TRIAL 32-72/74
04547898737275STD LINER TRIAL 40-66/68/70
04547898737268STD LINER TRIAL 36-66/68/70
04547898737251STD LINER TRIAL 32-66/68/70
04547898737244STD LINER TRIAL 40-60/62/64
04547898737237STD LINER TRIAL 36-60/62/64
04547898737220STD LINER TRIAL 32-60/62/64
04547898737213STD LINER TRIAL 40-56/58
04547898737206STD LINER TRIAL 36-56/58
04547898737190STD LINER TRIAL 32-56/58
04547898737183STD LINER TRIAL 36-52/54
04547898737176STD LINER TRIAL 32-52/54
04547898737169STD LINER TRIAL 36-50
04547898737152STD LINER TRIAL 32-50
04547898737145STD LINER TRIAL 28-50
04547898737138STD LINER TRIAL 32-48
04547898737121STD LINER TRIAL 28-48
04547898737114STD LINER TRIAL 32-46
04547898737107STD LINER TRIAL 28-46
04547898736933INITIA BROACH 10
04547898736926INITIA BROACH 9
04547898736919MALLET
04547898736902FEMORAL BROACH TRAY
04547898736513MX-HO LINER TRIAL 28-44
04547898736506MX-HO LINER TRIAL 28-50
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