Tritis

GUDID 10884521514102

Non Absorbable ACL Tibial Fixation System

Covidien LP

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10884521514102
• NIH Device Record Key: 751ad901-52d3-40ef-9134-2a59f2584ca9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tritis
• Version Model Number: 2641SS
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521514102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052810

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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: 2024-02-14
• Device Publish Date: 2015-10-22

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