TRIFIT STEM E090.125T

GUDID 05055196963047

Tri-Fit Hip Stem

CORIN LTD

Coated hip femur prosthesis, modular
Primary Device ID05055196963047
NIH Device Record Key02391b6d-02e6-4d26-83a4-01df14805d2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIFIT STEM
Version Model NumberE090.125T
Catalog NumberE090.125T
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105055196963047 [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

[05055196963047]

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 [TRIFIT STEM]

05055196963078Tri-Fit Hip Stem
05055196963061Tri-Fit Hip Stem
05055196963054Tri-Fit Hip Stem
05055196963047Tri-Fit Hip Stem
05055196963030Tri-Fit Hip Stem
05055196963023Tri-Fit Hip Stem

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