MIDAS REX MR8 CLEARVIEW BURS

GUDID 00763000513726

TOOL MR8-ND13BA30 MR8 13CM ND BALL 3MM

MEDTRONIC POWERED SURGICAL SOLUTIONS

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• Primary Device ID: 00763000513726
• NIH Device Record Key: 46187659-73ba-4ecb-9327-399a69993d41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIDAS REX MR8 CLEARVIEW BURS
• Version Model Number: MR8-ND13BA30
• 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	00763000513726 [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: 2022-04-05
• Device Publish Date: 2022-03-28

Devices Manufactured by MEDTRONIC POWERED SURGICAL SOLUTIONS

• 00763000714550 - MR8 Tools: 2024-05-06 TOOL MR8-14TD3030 MR8 TWIST DRL 3MMX30MM
• 00763000732943 - MR8: 2024-01-26 TOOL MR8-ND13BA30D MR8 13CM ND B D 3MM
• 00763000732967 - MR8: 2024-01-26 TOOL MR8-SD12BA30D MR8 12CM SD B D 3MM
• 00763000732974 - MR8: 2024-01-26 TOOL MR8-SD12BA40D MR8 12CM SD B D 4MM
• 00763000732981 - MR8: 2024-01-26 TOOL MR8-SD12BA30DC MR8 12CM SD B DC3MM
• 00763000732998 - MR8: 2024-01-26 TOOL MR8-SD12BA40DC MR8 12CM SD B DC4MM
• 00763000737276 - MR8: 2024-01-26 TOOL MR8-ND13BA40D MR8 13CM ND B D 4MM
• 00763000651152 - MR8: 2023-12-11 TOOL MR8-15MH30SH MR8 15CM 3MM MATCH SH