Midas Rex®

GUDID 00613994614605

HANDPIECE ED100RF SC1 REFURB

MEDTRONIC XOMED, INC.

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 00613994614605
• NIH Device Record Key: 2012ae6d-3fd7-4122-a8eb-748265447341
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midas Rex®
• Version Model Number: ED100RF
• 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	00613994614605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081475

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

[00613994614605]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-07-04

On-Brand Devices [Midas Rex®]

• 00613994633897: MOTOR EM210 LEGEND EHS STYLUS TOUCH
• 00613994614605: HANDPIECE ED100RF SC1 REFURB
• 00613994550446: SC1 HANDPIECE ED100LO LOANER
• 00643169945388: MOTOR EM210 LEGEND EHS STYLUS TOUCH ROHS
• 00643169945371: MOTOR EM210RF LEGEND STYLUS TOUCH REFURB
• 00643169931459: CONSOLE EC300RF IPC REFURB
• 00643169882805: HANDPIECE ED100RF SC1 REFURB
• 00643169882720: SC1 HANDPIECE ED100 ROHS
• 00643169360976: MOTOR EM210 LEGEND EHS STYLUS TOUCH ROHS
• 00643169350694: SC1 HANDPIECE ED100 ROHS