MR8 Stealth-Midas

GUDID 00763000063337

MOTOR EM800N-R MR8 ELEC NAVIGATED RFRB

MEDTRONIC PS MEDICAL, INC.

Line-powered surgical power tool system motor

• Primary Device ID: 00763000063337
• NIH Device Record Key: e1e9db0b-5784-4421-8be3-118153782a28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR8 Stealth-Midas
• Version Model Number: EM800N-R
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000063337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183644

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

[00763000063337]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-11
• Device Publish Date: 2020-05-01

On-Brand Devices [MR8 Stealth-Midas]

• 00763000063979: MOTOR PM800N-R MR8 PNEUM NAVIGATED RFRB
• 00763000063337: MOTOR EM800N-R MR8 ELEC NAVIGATED RFRB