Stratis 2050SS

GUDID 10884521513549

ACL Femoral Reconstruction System Kit

Covidien LP

Meniscus screw

• Primary Device ID: 10884521513549
• NIH Device Record Key: b8190a66-949e-4f00-b06a-adbd1bb5fdb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratis
• Version Model Number: 2050SS
• Catalog Number: 2050SS
• 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

Device Dimensions

• Outer Diameter: 25 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521513549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041961

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[10884521513549]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-24

On-Brand Devices [Stratis]

• 10884521513853: Retractable Switching Stick
• 10884521513839: Drill Tipped Guide Wire
• 10884521513822: Cannulated Acorn Drill Bit
• 10884521513815: Cannulated Acorn Drill Bit
• 10884521513808: Cannulated Acorn Drill Bit
• 10884521513792: Cannulated Drill Bit
• 10884521513785: Cannulated Drill Bit
• 10884521513778: Cannulated Drill Bit
• 10884521513693: ACL Reconstruction Graft Conditioning/Sizng Block
• 10884521513686: Transverse Drill
• 10884521513679: ACL System Sterilization Tray
• 10884521513648: Transverse Drill Sleeve
• 10884521513624: Drill Guide Handle Locking Nut
• 10884521513617: Transverse Drill Guide
• 10884521513570: Fixation Pin Inserter
• 10884521513549: ACL Femoral Reconstruction System Kit