HLS NOETOS

GUDID 03700386911774

TORNIER

Uncoated knee tibia prosthesis, metallic
Primary Device ID03700386911774
NIH Device Record Key640c7bb6-ca59-49c0-8e25-dcb15a17078b
Commercial Distribution Discontinuation2017-11-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHLS NOETOS
Version Model NumberGDF533
Company DUNS260324876
Company NameTORNIER
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+330476613500
Emailorder@tornier.com

Device Dimensions

Outer Diameter14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103700386911774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-11
Device Publish Date2015-10-16

On-Brand Devices [HLS NOETOS]

03700386912412GDF706
03700386912405GDF705
03700386912399GDF704
03700386912382GDF703
03700386912375GDF702
03700386912368GDF701
03700386912351GDF696
03700386912344GDF695
03700386912337GDF694
03700386912320GDF693
03700386912313GDF692
03700386912306GDF691
03700386911774GDF533
03700386911767GDF531
03700386910937GDF036
03700386910920GDF035
03700386910913GDF034
03700386910906GDF033
03700386910890GDF032
03700386910883GDF031
03700386911477GDF466
03700386911460GDF465
03700386911453GDF464
03700386911446GDF463
03700386911439GDF462
03700386911422GDF461
03700386911415GDF456
03700386911408GDF455
03700386911392GDF454
03700386911385GDF453
03700386911378GDF452
03700386911361GDF451
03700386911354GDF446
03700386911347GDF445
03700386911330GDF444
03700386911323GDF443
03700386911316GDF442
03700386911309GDF441
03700386911293GDF436
03700386911286GDF435
03700386911279GDF434
03700386911262GDF433
03700386911255GDF432
03700386911248GDF431
03700386911231GDF426
03700386911224GDF425
03700386911217GDF424
03700386911200GDF423
03700386911194GDF422
03700386911187GDF421

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