HLS NOETOS REVISION

GUDID 03700386912221

TORNIER

Uncoated knee femur prosthesis, metallic
Primary Device ID03700386912221
NIH Device Record Keyb41bd55c-f857-4f53-9a35-1177d8e8463b
Commercial Distribution Discontinuation2017-11-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHLS NOETOS REVISION
Version Model NumberGDF681
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 Identifiers

Device Issuing AgencyDevice ID
GS103700386912221 [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 REVISION]

03700386912290GDF689
03700386912283GDF688
03700386912276GDF687
03700386912269GDF685
03700386912245GDF683
03700386912238GDF682
03700386912221GDF681
03700386912214GDF680
03700386911958GDF566
03700386911934GDF564
03700386911927GDF563
03700386911910GDF562
03700386911903GDF561
03700386911897GDF556
03700386911880GDF555
03700386911873GDF554
03700386911859GDF552
03700386911842GDF551
03700386911835GDF546
03700386911828GDF545
03700386911811GDF544
03700386911804GDF543
03700386911798GDF542
03700386911781GDF541
03700386912252GDF684
03700386911941GDF565
03700386911866GDF553
03700386919602GDF527
03700386919596GDF526
03700386919589GDF517
03700386919572GDF516
03700386911750GDF525
03700386911743GDF524
03700386911736GDF523
03700386911729GDF522
03700386911712GDF521
03700386911705GDF515
03700386911699GDF514
03700386911682GDF513
03700386911675GDF512
03700386911668GDF511

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