MIDAS REX MR8

GUDID 00763000491673

TOOL MR8-26BA60D MR8 26CM BALL DMD 6MM

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, single-use

• Primary Device ID: 00763000491673
• NIH Device Record Key: 40b109a1-8a95-4771-a789-7ec3a580d255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIDAS REX MR8
• Version Model Number: MR8-26BA60D
• 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	00763000491673 [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: 2022-04-18
• Device Publish Date: 2022-04-08

On-Brand Devices [MIDAS REX MR8]

• 00763000200411: TUBE MR8-TT15H MR8 15CM TELESC HOODED A^
• 00763000007911: TOOL MR8-21MH30D MR8 21CM MATCH DMD 3MM
• 00763000007904: TOOL MR8-21CY65DX MR8 21CM CYL DX 6.5MM
• 00763000007898: TOOL MR8-21CY50 MR8 21CM CYL 5MM DIAM
• 00763000007874: TOOL MR8-21BA80DX MR8 21CM BALL DX 8MM
• 00763000007850: TOOL MR8-21BA70DX MR8 21CM BALL DX 7MM
• 00763000007843: TOOL MR8-21BA60DX MR8 21CM BALL DX 6MM
• 00763000007836: TOOL MR8-21BA60D MR8 21CM BALL DMD 6MM
• 00763000007812: TOOL MR8-21BA50DX MR8 21CM BALL DX 5MM
• 00763000007799: TOOL MR8-21BA40DX MR8 21CM BALL DX 4MM
• 00763000007775: TOOL MR8-21AC90 MR8 21CM ACORN 9MM
• 00763000007751: TOOL MR8-21AC60 MR8 21CM ACORN 6MM
• 00643169990470: TOOL MR8-15TA23 MR8 15CM TAPER 2.3MM
• 00643169990463: TOOL MR8-15MH40D MR8 15CM MATCH DMD 4MM
• 00643169990456: TOOL MR8-15MH30DC MR8 15CM MATCH DC 3MM
• 00643169990449: TOOL MR8-15MH30D MR8 15CM MATCH DMD 3MM
• 00643169990432: TOOL MR8-15MH17D MR8 15CM MATCH D 1.7MM
• 00643169990425: TOOL MR8-15MH17 MR8 15CM MATCHHEAD 1.7MM
• 00643169990418: TOOL MR8-15CY50L MR8 15CM CYL LONG 5MM
• 00643169990401: TOOL MR8-15CY50DCD MR8 15CM CYL DC D 5MM
• 00643169990395: TOOL MR8-15CY30DC MR8 15CM CYL DC 3MM
• 00643169990296: TOOL MR8-15BA30T MR8 15CM BAL SYMTRI 3MM
• 00643169990265: TOOL MR8-15AC60 MR8 15CM ACORN 6MM DIAM
• 00643169990258: TOOL MR8-15AC50 MR8 15CM ACORN 5MM DIAM
• 00643169990180: TOOL MR8-12BA50 MR8 12CM BALL 5MM DIAM
• 00643169990135: TOOL MR8-12BA30 MR8 12CM BALL 3MM DIAM
• 00643169990128: TOOL MR8-12BA20 MR8 12CM BALL 2MM DIAM
• 00643169989696: TOOL MR8-10TA23 MR8 10CM TAPER 2.3MM
• 00643169989689: TOOL MR8-10OV40D MR8 10CM OVAL DMD 4MM
• 00643169989672: TOOL MR8-10OV40 MR8 10CM OVAL 4MM DIAM
• 00643169989665: TOOL MR8-10MH40 MR8 10CM MATCH HEAD 4MM
• 00643169989658: TOOL MR8-10MH30DC MR8 10CM MATCH DC 3MM
• 00643169989641: TOOL MR8-10MH30D MR8 10CM MATCH DMD 3MM
• 00643169989634: TOOL MR8-10MH22D MR8 10CM MATCH D 2.2MM
• 00643169989627: TOOL MR8-10MH22 MR8 10CM MATCHHEAD 2.2MM
• 00643169989610: TOOL MR8-10MH17D MR8 10CM MATCH D 1.7MM
• 00643169989597: TOOL MR8-10CY60BR MR8 10CM CYL BARL 6MM
• 00643169989580: TOOL MR8-10CY60 MR8 10CM CYL 6MM DIAM
• 00643169989573: TOOL MR8-10CY50BR MR8 10CM CYL BARL 5MM
• 00643169989566: TOOL MR8-10CY50 MR8 10CM CYL 5MM DIAM
• 00643169989559: TOOL MR8-10CY40L MR8 10CM CYL LONG 4MM
• 00643169989542: TOOL MR8-10CY40BR MR8 10CM CYL BARL 4MM
• 00643169989535: TOOL MR8-10CY40 MR8 10CM CYL 4MM DIAM
• 00643169989528: TOOL MR8-10CY30BR MR8 10CM CYL BARL 3MM
• 00643169989511: TOOL MR8-10BA70DX MR8 10CM BAL DXCRS 7MM
• 00643169989504: TOOL MR8-10BA60F MR8 10CM BALL FINE 6MM
• 00643169989498: TOOL MR8-10BA60DX MR8 10CM BAL DXCRS 6MM
• 00643169989481: TOOL MR8-10BA60DF MR8 10CM BALL DF 6MM
• 00643169989474: TOOL MR8-10BA60D MR8 10CM BALL DMD 6MM
• 00643169989467: TOOL MR8-10BA60 MR8 10CM BALL 6MM DIAM