Indigo

GUDID 00763000172886

ATT 1845010-R INDIGO OTOL STRAIGHT RFURB

MEDTRONIC XOMED, INC.

Multi-purpose surgical power tool system, line-powered Multi-purpose surgical power tool system, line-powered Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic

• Primary Device ID: 00763000172886
• NIH Device Record Key: 1104e37d-4703-43b8-8235-89b68d9e69bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indigo
• Version Model Number: 1845010-R
• 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: true
• 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	00763000172886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081277

FDA Product Code

• HAB: SAW, POWERED, AND ACCESSORIES

Sterilization

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

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00763000172886]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-09-29

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