MR8 Tools

GUDID 00763000290283

TOOL MR8-9AC75M MR8 9CM ACORN 7.5MM 2FLT

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, single-use

• Primary Device ID: 00763000290283
• NIH Device Record Key: 388f6065-0c0b-496f-b7f5-a0ac8d64717e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR8 Tools
• Version Model Number: MR8-9AC75M
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000290283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183515

FDA Product Code

• HXZ: CUTTER, WIRE

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: 2023-05-19
• Device Publish Date: 2023-05-11

On-Brand Devices [MR8 Tools]

• 00763000714543: TOOL MR8-12BA50DC 12CM BALL 5MM DC
• 00763000714475: TOOL MR8-10TA16 10CM TAPER 1.6MM
• 00763000585211: TOOL MR8-7TA13 MR8 7CM TAPER 1.3MM
• 00763000447298: TOOL MR8-10MH30SH 10CM MATCH 3MM SHORT
• 00763000447281: TOOL MR8-12MH30SH 12CM MATCH 3MM SHORT
• 00763000290283: TOOL MR8-9AC75M MR8 9CM ACORN 7.5MM 2FLT
• 00763000714550: TOOL MR8-14TD3030 MR8 TWIST DRL 3MMX30MM