Indigo

GUDID 00763000172879

ATT 1845020 INDIGO OTOL ANGLED

MEDTRONIC XOMED, INC.

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 00763000172879
• NIH Device Record Key: 5d56e07e-6465-4bfb-8d0f-ecb9b3e2e322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indigo
• Version Model Number: 1845020
• 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	00763000172879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081475

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000172879]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-09-28

On-Brand Devices [Indigo]

• 00763000172893: ATT 1845020-R INDIGO OTOL ANGLED REFURB
• 00763000172886: ATT 1845010-R INDIGO OTOL STRAIGHT RFURB
• 00763000172879: ATT 1845020 INDIGO OTOL ANGLED
• 00763000172862: ATT 1845010 INDIGO OTOL STRAIGHT
• 00763000299217: INSTRUMENT TRAY 1845040 INDIGO