MIDAS REX STEALTH-MIDAS MR8

GUDID 00763000431020

MOTOR PM800N MR8 PNEUMATIC NAVIGATED S8

MEDTRONIC POWERED SURGICAL SOLUTIONS

Surgical power tool system handpiece, rotary, pneumatic
Primary Device ID00763000431020
NIH Device Record Key63811f34-a544-4870-b119-588b7739575c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIDAS REX STEALTH-MIDAS MR8
Version Model NumberPM800N
Company DUNS098308849
Company NameMEDTRONIC POWERED SURGICAL SOLUTIONS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
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
GS100763000431020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


[00763000431020]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-13
Device Publish Date2021-12-05

Devices Manufactured by MEDTRONIC POWERED SURGICAL SOLUTIONS

00763000714482 - MR82024-08-27 TOOL MR8-10MH17L MR8 10CM MATCH 1.7MM L
00763000714536 - MR82024-08-27 TOOL MR8-10BA80DC MR8 10CM BALL 8MM DC
00763000753382 - ENT MR82024-06-17 UR 1847B20SCT ENTMR8 CUT 2MM STD
00763000753412 - ENT MR82024-06-17 UR 1847B20SDM ENTMR8 DMD MED 2MM STD
00763000714550 - MR8 Tools2024-05-06 TOOL MR8-14TD3030 MR8 TWIST DRL 3MMX30MM
00763000732943 - MR82024-01-26 TOOL MR8-ND13BA30D MR8 13CM ND B D 3MM
00763000732967 - MR82024-01-26 TOOL MR8-SD12BA30D MR8 12CM SD B D 3MM
00763000732974 - MR82024-01-26 TOOL MR8-SD12BA40D MR8 12CM SD B D 4MM

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