Biolox Delta Modular Head 32mm MEDIUM 0.0mm 12/14 104.3205

GUDID 05055196964358

BIOLOX Delta Ceramic Head

CORIN LTD

Ceramic femoral head prosthesis
Primary Device ID05055196964358
NIH Device Record Keyf0dd4a97-fc6c-4e22-9fed-595f62603d75
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiolox Delta Modular Head 32mm MEDIUM 0.0mm 12/14
Version Model Number104.3205
Catalog Number104.3205
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
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055196964358 [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

[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

Radiation Sterilization


[05055196964358]

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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05056139252341 - Trinity EVO2025-07-10 Trinity™ EVO Cup Ø54mm Taper Size 4 uncoated
05056139252358 - Trinity EVO2025-07-10 Trinity™ EVO Cup Ø56mm Taper Size 4 uncoated

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