| Primary Device ID | 00763000063436 |
| NIH Device Record Key | 25f29def-0d15-4668-a733-908931e25806 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Midas Rex MR8 |
| Version Model Number | MR8-AA12DK-R |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000063436 [Primary] |
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000063436]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-02 |
| Device Publish Date | 2019-08-23 |
| 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 |