iDrive Ultra

GUDID 10884521144408

Reusable Manual Adapter Tool

Covidien LP

Surgical screwdriver, reusable

• Primary Device ID: 10884521144408
• NIH Device Record Key: 273de138-e87e-465d-b542-2e2ac10c5416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDrive Ultra
• Version Model Number: IDRVRET
• 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
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 279 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521144408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123318

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

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

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

[10884521144408]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-05-03
• Device Publish Date: 2015-09-02

On-Brand Devices [iDrive Ultra]

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