Biolox Delta Modular Head 28mm LONG +3.5mm 12/14 E 104.2810

GUDID 05055196964334

BIOLOX Delta Ceramic Head

CORIN LTD

Ceramic femoral head prosthesis
Primary Device ID05055196964334
NIH Device Record Key32209883-1cf8-411f-ae53-1ff5530ef902
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiolox Delta Modular Head 28mm LONG +3.5mm 12/14 E
Version Model Number104.2810
Catalog Number104.2810
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
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com
Phone+441285659866
Emailrachel.king@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055196964334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


[05055196964334]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-17

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