VISAO™

GUDID 00643169955646

GUARD 3334635 VISAO BUR W/IRRIGATION

MEDTRONIC XOMED, INC.

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 00643169955646
• NIH Device Record Key: 755ea431-ea05-4779-9f18-6f440f7a1526
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISAO™
• Version Model Number: 3334635
• 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	00643169955646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983224

FDA Product Code

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

Sterilization

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

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169955646]

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: 2018-06-29

On-Brand Devices [VISAO™]

• 00643169955646: GUARD 3334635 VISAO BUR W/IRRIGATION
• 00643169955639: GUARD 3334625 VISAO BUR W/O IRRIGATION
• 00643169789678: TRAY 3334895 VISAO DRILL STERILIZATION
• 00763000009489: SLEEVE 3334610 VISAO IRRIGATION
• 00885074107387: TRAY 3334895 VISAO DRILL STERILIZATION
• 00885074107370: SLEEVE 3334610 VISAO IRRIGATION
• 00885074107363: GUARD 3334635 VISAO BUR W/IRRIGATION
• 00885074107356: GUARD 3334625 VISAO BUR W/O IRRIGATION
• 00885074107349: DRILL 3334800T VISAO IGS 80K HANDPIECE
• 00885074107332: DRILL 3334800 VISAO 80K HANDPIECE