MIDAS REX MR8 CLEARVIEW BURS

GUDID 00763000513726

TOOL MR8-ND13BA30 MR8 13CM ND BALL 3MM

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, single-use
Primary Device ID00763000513726
NIH Device Record Key46187659-73ba-4ecb-9327-399a69993d41
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIDAS REX MR8 CLEARVIEW BURS
Version Model NumberMR8-ND13BA30
Company DUNS098308849
Company NameMEDTRONIC POWERED SURGICAL SOLUTIONS
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000513726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-05
Device Publish Date2022-03-28

Devices Manufactured by MEDTRONIC POWERED SURGICAL SOLUTIONS

00763000722326 - ENT MR82025-08-04 TUBING ENTMR8 1847CVTUBEA CLEARVIEW EA
00763000722340 - ENT MR82025-08-04 TUBING ENTMR8 1847IRTUBEA IRRIGATION EA
00763000722364 - MIDAS REX MICROSAWS2025-08-04 TUBING IRD410 MICROSAW FOOT-CONTROLLED
00763000722388 - MIDAS REX LEGEND2025-08-04 TUBING IRD450 EA IPC LOW PRO IRRIGATION
00763000722319 - ENT MR82025-08-04 TUBING ENTMR8 1847CVTUBBX CLEARVIEW 5PK
00763000722333 - ENT MR82025-08-04 TUBING ENTMR8 1847IRTUBBX IRRIGATION 5PK
00763000722357 - MIDAS REX LEGEND2025-08-04 TUBING IRD400 5PK IPC LOW PRO IRRIGATION
00763000722401 - MIDAS REX MR82025-07-29 TUBING IRD850 MR8 IRRIGATION EA

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