Trinity No Hole Shells 321.04.054

GUDID 05055343870648

Trinity-i No Hole Shell Ø54mm Taper Size 4

CORIN LTD

Acetabular shell
Primary Device ID05055343870648
NIH Device Record Key250dd14f-543e-4ddd-8477-39e485a792fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity No Hole Shells
Version Model Number321.04.054
Catalog Number321.04.054
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
GS105055343870648 [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

[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


[05055343870648]

Radiation Sterilization


Device Entry Metadata

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

On-Brand Devices [Trinity No Hole Shells]

05055343870648Trinity-i No Hole Shell Ø54mm Taper Size 4
05055343870631Trinity-i No Hole Shell Ø50mm Taper Size 3
05055343870624Trinity-i No Hole Shell Ø46mm Taper Size 2
05055343866573Trinity No Hole Shell Ø68mm Taper Size 5
05055343866566Trinity No Hole Shell Ø66mm Taper Size 5
05055343866559Trinity No Hole Shell Ø64mm Taper Size 5
05055343866542Trinity No Hole Shell Ø62mm Taper Size 5
05055343866535Trinity No Hole Shell Ø60mm Taper Size 5
05055343866528Trinity No Hole Shell Ø58mm Taper Size 4
05055343866511Trinity No Hole Shell Ø56mm Taper Size 4
05055343866504Trinity No Hole Shell Ø54mm Taper Size 3
05055343866498Trinity No Hole Shell Ø52mm Taper Size 3
05055343866481Trinity No Hole Shell Ø50mm Taper Size 2
05055343866474Trinity No Hole Shell Ø48mm Taper Size 2
05055343866467Trinity No Hole Shell Ø46mm Taper Size 1
05055343866450Trinity No Hole Shell Ø44mm Taper Size 1

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