iDrive Ultra IDRVULTRA2

GUDID 10884521510579

Reusable Powered Handle

Covidien LP

Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece Motorized cutting stapler handpiece

• Primary Device ID: 10884521510579
• NIH Device Record Key: 027d3b35-6078-4d51-b102-ef9431907683
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDrive Ultra
• Version Model Number: IDRVULTRA2
• Catalog Number: IDRVULTRA2
• 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
• 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
• 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
• 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
• 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

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521510579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121510

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

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

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

[10884521510579]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-01
• Device Publish Date: 2017-08-08

On-Brand Devices [iDrive Ultra]

• 10884521510579: Reusable Powered Handle
• 10884521144415: Reusable Sterilization Tray
• 10884521142794: Reusable Powered Handle
• 10884521144408: Reusable Manual Adapter Tool