Midas Rex ™

GUDID 00643169755222

BLADE 561R345-06-BAY R 56 X 35 MM BAY

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, single-use Orthopaedic bur, single-use

• Primary Device ID: 00643169755222
• NIH Device Record Key: e689c10a-f077-492b-98b5-972a0b0232b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midas Rex ™
• Version Model Number: 561R345-06-BAY
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169755222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081475

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-21

On-Brand Devices [Midas Rex ™]

• 00643169766464: TOOL T12RT40D LGND 12CM 4MM REV TAPR DIM
• 00643169766457: TOOL T12MH45D LEGEND 12CM 4.5MM DIAM
• 00643169766440: TOOL T12MH40DX LEGEND 12CM 4MM MATCH DX
• 00643169766433: TOOL T12MH35DC LGD 12CM 3.5MM MH CR DMND
• 00643169766426: TOOL T12MH35D LEGEND 12CM 3.5MM DIAM
• 00643169766419: TOOL T12MH30DX LEGEND 12CM 3MM MATCH DX
• 00643169766402: TOOL T12MH30DC LGD 12CM 3.0MM MH CR DMND
• 00643169766396: TOOL T12MH30D LEGEND 12CM 3MM DIAM
• 00643169766389: TOOL T12MH25L LGD 12CM 2.5MM MATCH LG
• 00643169766372: TOOL T12MH25D LEGEND 12CM 2.5MM DIAM
• 00643169766365: TOOL T12MH25 LEGEND 12CM 2.5MM MH
• 00643169766358: TOOL T12MH20D LEGEND 12CM 2MM DIAM
• 00643169766341: TOOL T12MH20 LEGEND 12CM 2MM MH
• 00643169766334: TOOL T12MH15D LEGND 12CM 1.5MM MACH DIAM
• 00643169766327: TOOL T12MH15 LEGEND 12CM 1.5MM MH
• 00643169766310: TOOL T12MH10D LEGEND 12CM 1MM MATCH DIAM
• 00643169766303: TOOL T12BA30D LGD T12CM 3MM BALL DIAM
• 00643169766297: TOOL T12BA20D LGD T12CM 2MM BALL DIAM
• 00643169766280: TOOL T12BA20 LEGD 12CM TELESC 2MM BALL
• 00643169765955: TOOL 8TD208 LEGEND 8CM 2MM 8MM DEPTH TD
• 00643169765948: TOOL 8TD206 LEGEND 8CM 2MM 6 MM DEPTH TD
• 00643169765931: TOOL 8TD204 LEGEND 8CM 2MM 4MM DEPTH TD
• 00643169765924: TOOL 8TD178 LEGEND 8CM 1.7MM 8MM DEPTH
• 00643169765917: TOOL 8TD176 LEGEND 8CM 1.7MM 6MM DEPTH
• 00643169765900: TOOL 8TD174 LEGEND 8CM 1.7MM 4MM DEPTH
• 00643169765894: TOOL 8TD158 LEGEND 8CM 1.5MM 8MM DEPTH
• 00643169765887: TOOL 8TD156 LEGEND 8CM 1.5MM 6MM DEPTH
• 00643169765870: TOOL 8TD154 LEGEND 8CM 1.5MM 4MM DEPTH
• 00643169765863: TOOL 8TD1520 LGD 8CM 1.5MMX20MM TWST DRL
• 00643169765856: TOOL 8TD1512 LGD 8CM 1.5MMX12MM TWST DRL
• 00643169765849: TOOL 8TD136 LEGEND 8CM 1.3MM 6MM DEPTH
• 00643169765832: TOOL 8TD134 LEGEND 8CM 1.3MM 4MM DEPTH
• 00643169765825: TOOL 8TD126 LEGEND 8CM 1.2MM 6MM DEPTH
• 00643169765818: TOOL 8TD124 LEGEND 8CM 1.2MM 4MM DEPTH
• 00643169765801: TOOL 8TD1219 LGND 8CM 1.2MM 19MM TWIST
• 00643169765795: TOOL 8TD116 LEGEND 8CM 1.1MM 6MM DEPTH
• 00643169765788: TOOL 8TD114 LEGEND 8CM 1.1MM 4MM TD
• 00643169765771: TOOL 8TD108 LGD 8CM 1.0MMX8MM TWST DRL
• 00643169765764: TOOL 8TD106 LGD 8CM 1.0MMX6MM TWST DRL
• 00643169765757: TOOL 8TD104 LEGEND 8CM 1MM 4MM DEPTH TD
• 00643169765740: TOOL 8TD088 LGD 8CM 0.8MMX8MM TWST DRL
• 00643169765733: TOOL 8TD085 LGD 8CM 0.8MMX5MM TWST DRL
• 00643169765726: TOOL 8TD084 LEGND 8CM 0.8MMX4MM TWST DRL
• 00643169765719: TOOL 8TD083 LGD 8CM 0.8MMX3MM TWST DRL
• 00643169765702: TOOL 8TD074 LGND 8CM 0.7MMX4MM TWST DRL
• 00643169765696: TOOL 8TA17 LEGEND 8CM 1.7MM TA
• 00643169765689: TOOL 8TA11 LEGEND 8CM 1.1MM TA
• 00643169765665: TOOL 7TD116 LGD 7CM 1.1MMX6MM TWIST DRIL
• 00643169765658: TOOL 7TD1117 LGD 7CM 1.1MMX17MM TWST DRL
• 00643169765641: TOOL 7TA21B LGND 7CM 2.1MM TAPR BL TIP C