Midas Rex MR8

GUDID 00763000374785

ACCY EA815 MR8 ELECTRIC CONTROL SWITCH

MEDTRONIC PS MEDICAL, INC.

Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch Surgical power tool hand-switch

• Primary Device ID: 00763000374785
• NIH Device Record Key: e5bc300f-eeef-46d7-baac-584b85153781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midas Rex MR8
• Version Model Number: EA815
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000374785 [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: true
• Device Is Sterile: false

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

[00763000374785]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-12
• Device Publish Date: 2020-10-03

On-Brand Devices [Midas Rex MR8]

• 00763000063986: MOTOR PM810-R MR8 PNEUMATIC TOUCH REFURB
• 00763000063962: MOTOR PM800-R MR8 PNEUMATIC REFURB
• 00763000063351: MOTOR EM850-R MR8 ELECTRIC PLUS REFURB
• 00763000063320: MOTOR EM800-R MR8 ELECTRIC REFURB
• 00763000063344: MOTOR EM810-R MR8 ELECTRIC TOUCH REFURB
• 00763000063924: ATT MR8-AVS15-R MR8 15CM VBL STR2.4MMRFB
• 00763000063917: ATT MR8-AVS14-R MR8 14CM VBL STR3.2MMRFB
• 00763000063900: ATT MR8-AVS12-R MR8 12CM VBL STR2.4MMRFB
• 00763000063894: ATT MR8-AVS10-R MR8 10CM VBL STR2.4MMRFB
• 00763000063887: ATT MR8-AVS09-R 9CM VRBL STRT 3.2MM RFRB
• 00763000063870: ATT MR8-AVS07-R 7CM VRBL STRT 2.4MM RFRB
• 00763000063856: ATT MR8-AVA15DK-R MR8 15CM VBL AG DK RFB
• 00763000063849: ATT MR8-AVA15-R MR8 15CM VBL AG 2.4MMRFB
• 00763000063832: ATT MR8-AVA14DK-R MR8 14CM VRBL AG DKRFB
• 00763000063825: ATT MR8-AVA14-R MR8 14CM VBL AG 3.2MMRFB
• 00763000063818: ATT MR8-AVA12DK-R MR8 12CM VRBL AG DKRFB
• 00763000063801: ATT MR8-AVA12-R MR8 12CM VBL AG 2.4MMRFB
• 00763000063795: ATT MR8-AVA10DK-R MR8 10CM VRBL AG DKRFB
• 00763000063788: ATT MR8-AVA10-R MR8 10CM VBL AG 2.4MMRFB
• 00763000063771: ATT MR8-AVA09DK-R MR8 9CM VRBL AG DK RFB
• 00763000063764: ATT MR8-AVA09-R MR8 9CM VRBL AG 3.2MMRFB
• 00763000063757: ATT MR8-AVA07DK-R MR8 7CM VRBL AG DK RFB
• 00763000063740: ATT MR8-AVA07-R MR8 7CM VRBL AG 2.4MMRFB
• 00763000063733: ATT MR8-AT10DK-R MR8 TELESC BASE DK RFRB
• 00763000063726: ATT MR8-AT10ADK-R MR8 TEL BSE ANG DK RFB
• 00763000063719: ATT MR8-AT10-R MR8 TELESCOPING BASE RFRB
• 00763000063702: ATT MR8-ASMC14-R MR8 14CM MTLCUT3.2MMRFB
• 00763000063696: ATT MR8-ASMC09-R MR8 9CM MTLCUT 3.2MMRFB
• 00763000063689: ATT MR8-ASJL-R MR8 J-LATCH 2.4MM REFURB
• 00763000063672: ATT MR8-AS26-R MR8 26CM STRT 3.2MM REFRB
• 00763000063665: ATT MR8-AS21-R MR8 21CM STRT 3.2MM REFRB
• 00763000063658: ATT MR8-AS18-R MR8 18CM STRT 2.4MM REFRB
• 00763000063641: ATT MR8-AS15-R MR8 15CM STRT 2.4MM REFRB
• 00763000063634: ATT MR8-AS14-R MR8 14CM STRT 3.2MM REFRB
• 00763000063627: ATT MR8-AS12-R MR8 12CM STRT 2.4MM REFRB
• 00763000063610: ATT MR8-AS10-R MR8 10CM STRT 2.4MM REFRB
• 00763000063603: ATT MR8-AS09-R MR8 9CM STRT 3.2MM REFURB
• 00763000063597: ATT MR8-AS07-R MR8 7CM STRT 2.4MM REFURB
• 00763000063580: ATT MR8-AF03-R MR8 FTD F3 S-1 3.2MM RFRB
• 00763000063573: ATT MR8-AF02R-R MR8 FTD ROTAT F2 B-1 RFB
• 00763000063566: ATT MR8-AF02-R MR8 FTD F2 B-1 2.4MM RFRB
• 00763000063559: ATT MR8-AF01R-R MR8 FTD ROTAT F1 B-5 RFB
• 00763000063542: ATT MR8-AF01-R MR8 FTD F1 B-5 2.4MM RFRB
• 00763000063535: ATT MR8-AD03-R MR8 PERF DRVR 1000RPM RFB
• 00763000063528: ATT MR8-AD02-R MR8 DRVR JACB CHK 5/32RFB
• 00763000063511: ATT MR8-AA21DK-R MR8 21CM ANG DK3.2MMRFB
• 00763000063504: ATT MR8-AA21-R MR8 21CM ANGLD 3.2MM RFRB
• 00763000063498: ATT MR8-AA18DK-R MR8 18CM ANG DK2.4MMRFB
• 00763000063481: ATT MR8-AA18-R MR8 18CM ANGLD 2.4MM RFRB
• 00763000063474: ATT MR8-AA15DK-R MR8 15CM ANG DK2.4MMRFB