Midas Rex MR8

GUDID 00643169912137

MOTOR PM800 MR8 PNEUMATIC

MEDTRONIC POWERED SURGICAL SOLUTIONS

Surgical power tool system handpiece, rotary, pneumatic
Primary Device ID00643169912137
NIH Device Record Keyf6776cfd-2dcf-447f-a15c-0b3f9e079ae5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMidas Rex MR8
Version Model NumberPM800
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169912137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

[00643169912137]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-17
Device Publish Date2019-06-08

On-Brand Devices [Midas Rex MR8]

00763000200411TUBE MR8-TT15H MR8 15CM TELESC HOODED A^
00763000007911TOOL MR8-21MH30D MR8 21CM MATCH DMD 3MM
00763000007904TOOL MR8-21CY65DX MR8 21CM CYL DX 6.5MM
00763000007898TOOL MR8-21CY50 MR8 21CM CYL 5MM DIAM
00763000007874TOOL MR8-21BA80DX MR8 21CM BALL DX 8MM
00763000007850TOOL MR8-21BA70DX MR8 21CM BALL DX 7MM
00763000007843TOOL MR8-21BA60DX MR8 21CM BALL DX 6MM
00763000007836TOOL MR8-21BA60D MR8 21CM BALL DMD 6MM
00763000007812TOOL MR8-21BA50DX MR8 21CM BALL DX 5MM
00763000007799TOOL MR8-21BA40DX MR8 21CM BALL DX 4MM
00763000007775TOOL MR8-21AC90 MR8 21CM ACORN 9MM
00763000007751TOOL MR8-21AC60 MR8 21CM ACORN 6MM
00643169990470TOOL MR8-15TA23 MR8 15CM TAPER 2.3MM
00643169990463TOOL MR8-15MH40D MR8 15CM MATCH DMD 4MM
00643169990456TOOL MR8-15MH30DC MR8 15CM MATCH DC 3MM
00643169990449TOOL MR8-15MH30D MR8 15CM MATCH DMD 3MM
00643169990432TOOL MR8-15MH17D MR8 15CM MATCH D 1.7MM
00643169990425TOOL MR8-15MH17 MR8 15CM MATCHHEAD 1.7MM
00643169990418TOOL MR8-15CY50L MR8 15CM CYL LONG 5MM
00643169990401TOOL MR8-15CY50DCD MR8 15CM CYL DC D 5MM
00643169990395TOOL MR8-15CY30DC MR8 15CM CYL DC 3MM
00643169990296TOOL MR8-15BA30T MR8 15CM BAL SYMTRI 3MM
00643169990265TOOL MR8-15AC60 MR8 15CM ACORN 6MM DIAM
00643169990258TOOL MR8-15AC50 MR8 15CM ACORN 5MM DIAM
00643169990180TOOL MR8-12BA50 MR8 12CM BALL 5MM DIAM
00643169990135TOOL MR8-12BA30 MR8 12CM BALL 3MM DIAM
00643169990128TOOL MR8-12BA20 MR8 12CM BALL 2MM DIAM
00643169989696TOOL MR8-10TA23 MR8 10CM TAPER 2.3MM
00643169989689TOOL MR8-10OV40D MR8 10CM OVAL DMD 4MM
00643169989672TOOL MR8-10OV40 MR8 10CM OVAL 4MM DIAM
00643169989665TOOL MR8-10MH40 MR8 10CM MATCH HEAD 4MM
00643169989658TOOL MR8-10MH30DC MR8 10CM MATCH DC 3MM
00643169989641TOOL MR8-10MH30D MR8 10CM MATCH DMD 3MM
00643169989634TOOL MR8-10MH22D MR8 10CM MATCH D 2.2MM
00643169989627TOOL MR8-10MH22 MR8 10CM MATCHHEAD 2.2MM
00643169989610TOOL MR8-10MH17D MR8 10CM MATCH D 1.7MM
00643169989597TOOL MR8-10CY60BR MR8 10CM CYL BARL 6MM
00643169989580TOOL MR8-10CY60 MR8 10CM CYL 6MM DIAM
00643169989573TOOL MR8-10CY50BR MR8 10CM CYL BARL 5MM
00643169989566TOOL MR8-10CY50 MR8 10CM CYL 5MM DIAM
00643169989559TOOL MR8-10CY40L MR8 10CM CYL LONG 4MM
00643169989542TOOL MR8-10CY40BR MR8 10CM CYL BARL 4MM
00643169989535TOOL MR8-10CY40 MR8 10CM CYL 4MM DIAM
00643169989528TOOL MR8-10CY30BR MR8 10CM CYL BARL 3MM
00643169989511TOOL MR8-10BA70DX MR8 10CM BAL DXCRS 7MM
00643169989504TOOL MR8-10BA60F MR8 10CM BALL FINE 6MM
00643169989498TOOL MR8-10BA60DX MR8 10CM BAL DXCRS 6MM
00643169989481TOOL MR8-10BA60DF MR8 10CM BALL DF 6MM
00643169989474TOOL MR8-10BA60D MR8 10CM BALL DMD 6MM
00643169989467TOOL MR8-10BA60 MR8 10CM BALL 6MM DIAM
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