MR8

GUDID 00763000714536

TOOL MR8-10BA80DC MR8 10CM BALL 8MM DC

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, single-use

• Primary Device ID: 00763000714536
• NIH Device Record Key: 32af749c-36db-4187-a6bb-15c3b9651ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR8
• Version Model Number: MR8-10BA80DC
• 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: false
• 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	00763000714536 [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: 2024-08-27
• Device Publish Date: 2024-08-19

On-Brand Devices [MR8]

• 00763000732868: HOSE PC730 MR8 REGULATOR INSTRUMENT AIR
• 00763000865634: TOOL MR8-12BA50DC 12CM BALL 5MM DC
• 00763000865627: TOOL MR8-10TA16 10CM TAPER 1.6MM
• 00763000714642: TOOL MR8-12MH30SH 12CM MATCH 3MM SHORT
• 00763000714635: TOOL MR8-10MH30SH 10CM MATCH 3MM SHORT
• 00763000651152: TOOL MR8-15MH30SH MR8 15CM 3MM MATCH SH
• 00763000737276: TOOL MR8-ND13BA40D MR8 13CM ND B D 4MM
• 00763000732998: TOOL MR8-SD12BA40DC MR8 12CM SD B DC4MM
• 00763000732981: TOOL MR8-SD12BA30DC MR8 12CM SD B DC3MM
• 00763000732974: TOOL MR8-SD12BA40D MR8 12CM SD B D 4MM
• 00763000732967: TOOL MR8-SD12BA30D MR8 12CM SD B D 3MM
• 00763000732943: TOOL MR8-ND13BA30D MR8 13CM ND B D 3MM
• 00763000714536: TOOL MR8-10BA80DC MR8 10CM BALL 8MM DC
• 00763000714482: TOOL MR8-10MH17L MR8 10CM MATCH 1.7MM L