Indigo™

GUDID 00613994933713

DRILL 1845000 INDIGO HIGH SPD OTOL ROHS

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: 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