HLS NOETOS REVISION

GUDID 03700386912290

TORNIER

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 03700386912290
• NIH Device Record Key: 03b41e8b-fa28-4dc6-a8f6-6d2b6622540f
• Commercial Distribution Discontinuation: 2017-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HLS NOETOS REVISION
• Version Model Number: GDF689
• Company DUNS: 260324876
• Company Name: TORNIER
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330476613500
• Email: order@tornier.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700386912290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032079

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-10-16

On-Brand Devices [HLS NOETOS REVISION]

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