MIDS REX MR8

GUDID 00763000487331

TOOL MR8-10BA50FL MR8 10CM BALL F LG 5MM

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, single-use

• Primary Device ID: 00763000487331
• NIH Device Record Key: 00e49f00-31c3-4dfb-b4cf-d0b247d66300
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIDS REX MR8
• Version Model Number: MR8-10BA50FL
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000487331 [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: 2022-01-10
• Device Publish Date: 2022-01-01

On-Brand Devices [MIDS REX MR8]

• 00763000487607: TOOL MR8-10TA23 MR8 10CM TAPER 2.3MM
• 00763000487591: TOOL MR8-10OV40D MR8 10CM OVAL DMD 4MM
• 00763000487584: TOOL MR8-10OV40 MR8 10CM OVAL 4MM DIAM
• 00763000487577: TOOL MR8-10MH40 MR8 10CM MATCH HEAD 4MM
• 00763000487560: TOOL MR8-10MH30DC MR8 10CM MATCH DC 3MM
• 00763000487553: TOOL MR8-10MH30D MR8 10CM MATCH DMD 3MM
• 00763000487539: TOOL MR8-10MH22D MR8 10CM MATCH D 2.2MM
• 00763000487522: TOOL MR8-10MH22 MR8 10CM MATCHHEAD 2.2MM
• 00763000487515: TOOL MR8-10MH17D MR8 10CM MATCH D 1.7MM
• 00763000487508: TOOL MR8-10MH17 MR8 10CM MATCHHEAD 1.7MM
• 00763000487492: TOOL MR8-10CY65DX MR8 10CM CYL DX 6.5MM
• 00763000487485: TOOL MR8-10CY60BR MR8 10CM CYL BARL 6MM
• 00763000487478: TOOL MR8-10CY60 MR8 10CM CYL 6MM DIAM
• 00763000487461: TOOL MR8-10CY50L MR8 10CM CYL LNG 5MM
• 00763000487454: TOOL MR8-10CY50BR MR8 10CM CYL BARL 5MM
• 00763000487447: TOOL MR8-10CY50 MR8 10CM CYL 5MM DIAM
• 00763000487430: TOOL MR8-10CY40L MR8 10CM CYL LONG 4MM
• 00763000487423: TOOL MR8-10CY40BR MR8 10CM CYL BARL 4MM
• 00763000487416: TOOL MR8-10CY40 MR8 10CM CYL 4MM DIAM
• 00763000487409: TOOL MR8-10CY30BR MR8 10CM CYL BARL 3MM
• 00763000487393: TOOL MR8-10BA70DX MR8 10CM BAL DXCRS 7MM
• 00763000487386: TOOL MR8-10BA60F MR8 10CM BALL FINE 6MM
• 00763000487379: TOOL MR8-10BA60DX MR8 10CM BAL DXCRS 6MM
• 00763000487362: TOOL MR8-10BA60DF MR8 10CM BALL DF 6MM
• 00763000487355: TOOL MR8-10BA60D MR8 10CM BALL DMD 6MM
• 00763000487348: TOOL MR8-10BA60 MR8 10CM BALL 6MM DIAM
• 00763000487331: TOOL MR8-10BA50FL MR8 10CM BALL F LG 5MM
• 00763000487324: TOOL MR8-10BA50F MR8 10CM BALL FINE 5MM
• 00763000487317: TOOL MR8-10BA50DX MR8 10CM BAL DXCRS 5MM
• 00763000487300: TOOL MR8-10BA50DF MR8 10CM BALL DF 5MM
• 00763000487294: TOOL MR8-10BA50DC MR8 10CM BALL DC 5MM
• 00763000487287: TOOL MR8-10BA50D MR8 10CM BALL DMD 5MM
• 00763000487263: TOOL MR8-10BA40T MR8 10CM BAL SYMTRI 4MM
• 00763000487256: TOOL MR8-10BA40F MR8 10CM BALL FINE 4MM
• 00763000487249: TOOL MR8-10BA40DX MR8 10CM BAL DXCRS 4MM
• 00763000487232: TOOL MR8-10BA40DF MR8 10CM BALL D F 4MM
• 00763000487225: TOOL MR8-10BA40DC MR8 10CM BALL D C 4MM
• 00763000487218: TOOL MR8-10BA40D MR8 10CM BALL D 4MM
• 00763000487188: TOOL MR8-10BA30T MR8 10CM BAL SYMTRI 3MM
• 00763000487171: TOOL MR8-10BA30FL MR8 10CM BALL F L 3MM
• 00763000487164: TOOL MR8-10BA30F MR8 10CM BALL FINE 3MM
• 00763000487157: TOOL MR8-10BA30DFL MR8 10CM BALL DFL 3MM
• 00763000487133: TOOL MR8-10BA30DC MR8 10CM BALL DC 3MM
• 00763000487126: TOOL MR8-10BA30D MR8 10CM BALL DMD 3MM
• 00763000487119: TOOL MR8-10BA30 MR8 10CM BALL 3MM DIAM
• 00763000487102: TOOL MR8-10BA20F MR8 10CM BALL FINE 2MM
• 00763000487096: TOOL MR8-10BA20DFL MR8 10CM BAL DF L 2MM
• 00763000487089: TOOL MR8-10BA20DF MR8 10CM BALL D F 2MM
• 00763000487072: TOOL MR8-10BA20D MR8 10CM BALL D 2MM
• 00763000487065: TOOL MR8-10BA20 MR8 10CM BALL 2MM DIAM