StratPac 2068SS

GUDID 10884521548343

Instrument Kit

Covidien LP

Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw 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

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• 10884521744141 - TruClear: 2024-04-23 Calibration Insert
• 10884521557048 - INVOS: 2024-04-22 Docking Station
• 10884521833869 - Endoflip: 2024-04-22 Refurbished 300 Pump System With Pre-Use Tube
• 20884521140216 - ClosureFast: 2024-04-15 Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m)
• 10884521543430 - LiquiBand Exceed: 2024-04-15 2-Octyl Cyanoacrylate
• 20884521140209 - ClosureFast: 2024-04-10 Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
• 10884521539921 - VenaSeal: 2024-04-09 VenaSeal Closure System