CoCr Modular Head extra short E321.440

GUDID 05055343885116

Trinity CoCrMo Modular Head 40mm EXTRA SHORT -8.0mm

CORIN LTD

Metallic femoral head prosthesis
Primary Device ID05055343885116
NIH Device Record Key811b67f7-e28b-4f95-add5-66f154826bdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoCr Modular Head extra short
Version Model NumberE321.440
Catalog NumberE321.440
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
GS105055343885116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05055343885116]

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 [CoCr Modular Head extra short]

05055343885123Trinity CoCrMo Modular Head 28mm EXTRA LONG +7.0mm
05055343885116Trinity CoCrMo Modular Head 40mm EXTRA SHORT -8.0mm
05055343885109Trinity CoCrMo Modular Head 36mm EXTRA SHORT -8.0mm
05055343885093Trinity CoCrMo Modular Head 32mm EXTRA SHORT -6.0mm
05055343885086Trinity CoCrMo Modular Head 28mm EXTRA SHORT -5.0mm

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