Indigo™

GUDID 00613994933713

DRILL 1845000 INDIGO HIGH SPD OTOL ROHS

MEDTRONIC XOMED, INC.

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 00613994933713
• NIH Device Record Key: c2626240-5109-46c3-8460-2d3a512ac676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indigo™
• Version Model Number: 1845000
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• 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: false
• Serial Number: true
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994933713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081277

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00613994933713]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-05-13

On-Brand Devices [Indigo™]

• 00613994933713: DRILL 1845000 INDIGO HIGH SPD OTOL ROHS
• 00613994933706: ATTACHMENT 1845010 INDIGO OTOL STRAIGHT
• 00613994933690: ATTACHMENT 1845020 INDIGO OTOL ANGLED
• 20613994933687: TUBING 1845030 INDIGO 5PK
• 00613994933676: INSTRUMENT TRAY 1845040 INDIGO
• 00643169882621: DRILL 1845000 INDIGO HIGH SPD OTOL ROHS
• 00643169789609: INSTRUMENT TRAY 1845040 INDIGO
• 00643169591202: BUR 31310584 INDIGO RND STEEL CUT 0.5MM
• 00643169591196: BUR 31311084 INDIGO RND STEEL CUT 1.0MM
• 00643169579309: BUR 31313079 INDIGO RND STEEL CUT 3.0MM
• 00643169579262: BUR 31311583 INDIGO RND STEEL CUT 1.5MM
• 00643169579255: BUR 31312080 INDIGO RND STEEL CUT 2.0MM
• 00643169579248: BUR 31312579 INDIGO RND STEEL CUT 2.5MM
• 00763000172091: INSTRUMENT TRAY 1845040 INDIGO