Midas Rex™ MR8™

GUDID 00763000595296

TOOL MR8-DS1TD32 MR8 TWST DRILL DS 3.2MM

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use

• Primary Device ID: 00763000595296
• NIH Device Record Key: 7ac34f18-5399-474f-8f0a-2beb6f39882f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midas Rex™ MR8™
• Version Model Number: MR8-DS1TD32
• Company DUNS: 098308849
• Company Name: MEDTRONIC POWERED SURGICAL SOLUTIONS
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000595296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213454

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

On-Brand Devices [Midas Rex™ MR8™]

• 00763000595302: TOOL MR8-DS1TD32L MR8 TWSTDRL DS L 3.2MM
• 00763000595296: TOOL MR8-DS1TD32 MR8 TWST DRILL DS 3.2MM
• 00763000595289: TOOL MR8-DS1TD24 MR8 TWST DRILL DS 2.4MM
• 00763000595272: TOOL MR8-DS1TD75 MR8 TWST DRILL DS 7.5MM
• 00763000595258: ATT MR8-ASDS01 MR8 STRAIGHT DEPTH STOP