Tritis 2163SS

GUDID 10884521513983

Tibial Tunnel Length Gauge

Covidien LP

Meniscus screw

• Primary Device ID: 10884521513983
• NIH Device Record Key: d4ec3e5c-dbc0-4926-93f9-e6948db66e2e
• Commercial Distribution Discontinuation: 2019-03-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tritis
• Version Model Number: 2163SS
• Catalog Number: 2163SS
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521513983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052810

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

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

[10884521513983]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-04-01
• Device Publish Date: 2016-09-24

On-Brand Devices [Tritis]

• 10884521514133: Nitinol Guide Wire
• 10884521513983: Tibial Tunnel Length Gauge
• 10884521513952: Inserter Stylus
• 10884521513907: Graft Dilator
• 10884521514126: Non Absorbable ACL Tibial Fixation System
• 10884521514119: Non Absorbable ACL Tibial Fixation System
• 10884521514027: Fixation Screw Driver
• 10884521514010: Implant Removal Tool
• 10884521514003: Hand Instrument Removal Tool
• 10884521513990: Graft Dilator
• 10884521513945: Graft Cleat Inserter
• 10884521513938: Inserter Stylus
• 10884521513921: Inserter Collet
• 10884521513914: Graft Dilator
• 10884521513891: Graft Dilator
• 10884521513884: Graft Dilator
• 10884521513877: ACL Tibial Reconstruction System Kit
• 10884521514102: Non Absorbable ACL Tibial Fixation System
• 10884521514096: Non Absorbable ACL Tibial Fixation System
• 10884521514089: Non Absorbable ACL Tibial Fixation System
• 10884521514072: Non Absorbable ACL Tibial Fixation System
• 10884521514065: Non Absorbable ACL Tibial Fixation System
• 10884521514058: Non Absorbable ACL Tibial Fixation System
• 10884521514034: Non Absorbable ACL Tibial Fixation System