StratPac 2068SS

GUDID 10884521548343

Instrument Kit

Covidien LP

Meniscus screw

• Primary Device ID: 10884521548343
• NIH Device Record Key: c7fa3c76-4051-46f7-b8e2-b040903d6420
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StratPac
• Version Model Number: 2068SS
• Catalog Number: 2068SS
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521548343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041749

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

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

Devices Manufactured by Covidien LP

• 20884521850115 - McGRATH MAC: 2025-05-05 Disposable Laryngoscope Blade 3
• 20884521850122 - McGRATH MAC: 2025-05-05 Disposable Laryngoscope Blade 4
• 20884521850139 - McGRATH MAC: 2025-05-05 Disposable Laryngoscope Blade 2
• 30884521850143 - McGRATH MAC: 2025-05-05 Disposable Laryngoscope Blade 1
• 10884521851559 - Vital Sync: 2025-05-05 VITAL SYNC Mobile V4 SOFTWARE
• 20884521084992 - DAR: 2025-04-21 Catheter Mount
• 20884521842530 - DAR: 2025-04-21 Catheter Mount Extension Tube
• 20884521844770 - DAR: 2025-04-21 Catheter Mount Extendable Extension Tube