Optimom Modular Heads E079.844

GUDID 05055196905542

OPTIMOM HEAD (12/14) SIZE 4/44mm 0 OFFSET

CORIN LTD

Metallic femoral head prosthesis
Primary Device ID05055196905542
NIH Device Record Key7f93d1a6-97a6-481f-8246-0e6354301277
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptimom Modular Heads
Version Model NumberE079.844
Catalog NumberE079.844
Company DUNS295437313
Company NameCORIN LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone+441285659866
Emaillucinda.gerber@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055196905542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, hip, hemi-, femoral, metal

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05055196905542]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2016-08-17

On-Brand Devices [Optimom Modular Heads]

05055196972919OPTIMOM TRIAL HEAD 10/56MM STD
05055196972902OPTIMOM TRIAL HEAD 10/56MM SHORT
05055196972889OPTIMOM TRIAL HEAD 8/52MM STD
05055196972872OPTIMOM TRIAL HEAD 8/52MM SHORT
05055196972858OPTIMOM TRIAL HEAD 6/48MM TRIAL STD
05055196972841OPTIMOM TRIAL HEAD 6/48MM SHORT
05055196972827OPTIMOM TRIAL HEAD 4/44MM STD
05055196972810OPTIMOM TRIAL HEAD 4/44MM SHORT
05055196906860OPTIMOM TRIAL HEAD 10/56MM LONG
05055196906853OPTIMOM TRIAL HEAD 9/54MM LONG
05055196906846OPTIMOM TRIAL HEAD 8/52MM LONG
05055196906839OPTIMOM TRIAL HEAD 7/50MM LONG
05055196906822OPTIMOM TRIAL HEAD 6/48MM LONG
05055196906815OPTIMOM TRIAL HEAD 5/46MM LONG
05055196906808OPTIMOM TRIAL HEAD 4/44MM LONG
05055196906341OPTIMOM TRIAL HEAD 9/54MM STD
05055196906334OPTIMOM TRIAL HEAD 9/54MM SHORT
05055196906310OPTIMOM TRIAL HEAD 7/50MM STD
05055196906303OPTIMOM TRIAL HEAD 7/50MM SHORT
05055196906280OPTIMOM TRIAL HEAD 5/46MM STD
05055196906273OPTIMOM TRIAL HEAD 5/46MM SHORT
05055196906198OPTIMOM HEAD (12/14) SIZE 9/54mm 0 OFFSET
05055196906181OPTIMOM HEAD (12/14) SIZE 7/50mm 0 OFFSET
05055196906174OPTIMOM HEAD (12/14) SIZE 5/46mm 0 OFFSET
05055196906167OPTIMOM HEAD (12/14) SIZE 3/42mm 0 OFFSET
05055196906150OPTIMOM HEAD (12/14) SIZE 9/54mm -4 OFFSET
05055196906143OPTIMOM HEAD (12/14) SIZE 7/50mm -4 OFFSET
05055196906136OPTIMOM HEAD (12/14) SIZE 5/46mm -4 OFFSET
05055196906129OPTIMOM HEAD (12/14) SIZE 3/42mm -4 OFFSET
05055196906112OPTIMOM HEAD (12/14) SIZE 9/54mm +4 OFFSET
05055196906105OPTIMOM HEAD (12/14) SIZE 7/50mm +4 OFFSET
05055196906099OPTIMOM HEAD (12/14) SIZE 5/46mm +4 OFFSET
05055196906082OPTIMOM HEAD (12/14) SIZE 3/42mm +4 OFFSET
05055196905849OPTIMOM HEAD (12/14) SIZE 10/56mm -4 OFFSET
05055196905832OPTIMOM HEAD (12/14) SIZE 8/52mm -4 OFFSET
05055196905825OPTIMOM HEAD (12/14) SIZE 6/48mm -4 OFFSET
05055196905818OPTIMOM HEAD (12/14) SIZE 4/44mm -4 OFFSET
05055196905801OPTIMOM HEAD (12/14) SIZE 2/40mm -4 OFFSET
05055196905795OPTIMOM HEAD (12/14) SIZE 10/56mm +4 OFFSET
05055196905788OPTIMOM HEAD (12/14) SIZE 8/52mm +4 OFFSET
05055196905771OPTIMOM HEAD (12/14) SIZE 6/48mm +4 OFFSET
05055196905764OPTIMOM HEAD (12/14) SIZE 4/44mm +4 OFFSET
05055196905757OPTIMOM HEAD (12/14) SIZE 2/40mm +4 OFFSET
05055196905573OPTIMOM HEAD (12/14) SIZE 10/56mm 0 OFFSET
05055196905566OPTIMOM HEAD (12/14) SIZE 8/52mm 0 OFFSET
05055196905559OPTIMOM HEAD (12/14) SIZE 6/48mm 0 OFFSET
05055196905542OPTIMOM HEAD (12/14) SIZE 4/44mm 0 OFFSET
05055196905535OPTIMOM HEAD (12/14) SIZE 2/40mm 0 OFFSET
05055196902756OPTIMOM HEAD IMPACTOR
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