AutoSonix 012034

GUDID 20884521058313

Hook Probe

Covidien LP

Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system

• Primary Device ID: 20884521058313
• NIH Device Record Key: 4ce48131-5345-4dc4-b3d9-fccc1d476aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoSonix
• Version Model Number: 012034
• Catalog Number: 012034
• 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

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521058316 [Primary]
GS1	20884521058313 [Package]; Contains: 10884521058316; Package: CASE [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971861

FDA Product Code

• LFL: Instrument, ultrasonic surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-11
• Device Publish Date: 2018-08-10

On-Brand Devices [AutoSonix]

• 20884521058313: Hook Probe
• 20884521058306: Shears
• 20884521058276: Shears
• 10884521058194: Transducer
• 10884521058187: Transducer Cable
• 20884521058344: Hook Probe
• 10884521058330: Adapter Box
• 10884521058231: Silencer Plug
• 20884521058160: Shears
• 10884521058200: Cart