MIDAS REX MR8 CLEARVIEW BURS

GUDID 00763000513726

TOOL MR8-ND13BA30 MR8 13CM ND BALL 3MM

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, single-use

• Primary Device ID: 00763000513726
• NIH Device Record Key: 46187659-73ba-4ecb-9327-399a69993d41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIDAS REX MR8 CLEARVIEW BURS
• Version Model Number: MR8-ND13BA30
• Company DUNS: 098308849
• Company Name: MEDTRONIC POWERED SURGICAL SOLUTIONS
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000513726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183515

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: 2022-04-05
• Device Publish Date: 2022-03-28

Devices Manufactured by MEDTRONIC POWERED SURGICAL SOLUTIONS

• 00721902573613 - MIDAS REX: 2025-04-04 MOTOR EM200 LEGEND EHS STYLUS
• 00763000651169 - Midas Rex MR8: 2025-03-31 TOOL MR8-9AC60M MR8 9CM ACORN 6MM 2FLT
• 00763000521813 - MIDAS REX LEGEND: 2025-03-28 ACCY PC230 LEGEND 30 FT EXTENSION HOSE
• 00763000930837 - MIDAS REX MR8: 2024-10-11 TOOL MR8-9MH30P260 9CM MATCH 3MM P260MM
• 00763000714482 - MR8: 2024-08-27 TOOL MR8-10MH17L MR8 10CM MATCH 1.7MM L
• 00763000714536 - MR8: 2024-08-27 TOOL MR8-10BA80DC MR8 10CM BALL 8MM DC
• 00763000753382 - ENT MR8: 2024-06-17 UR 1847B20SCT ENTMR8 CUT 2MM STD
• 00763000753412 - ENT MR8: 2024-06-17 UR 1847B20SDM ENTMR8 DMD MED 2MM STD