| Primary Device ID | 00763000356200 |
| NIH Device Record Key | 29580ec7-aaf1-45d9-9dfb-83834a507ee2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENT MR8 |
| Version Model Number | 1847B40SDF |
| Company DUNS | 098308849 |
| Company Name | MEDTRONIC POWERED SURGICAL SOLUTIONS |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000356200 [Primary] |
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-12 |
| Device Publish Date | 2020-10-02 |
| 00763000356712 | BUR ENTMR8 1847B40SDX DMD XCRS 4MM STD |
| 00763000356705 | BUR ENTMR8 1847B50SDX DMD XCRS 5MM STD |
| 00763000356699 | BUR ENTMR8 1847B60SDX DMD XCRS 6MM STD |
| 00763000356682 | BUR ENTMR8 1847B10LDC DMD CRS 1MM LNG |
| 00763000356675 | BUR ENTMR8 1847B15LDC DMD CRS 1.5MM LNG |
| 00763000356668 | BUR ENTMR8 1847B20LDC DMD CRS 2MM LNG |
| 00763000356651 | BUR ENTMR8 1847B30LDC DMD CRS 3MM LNG |
| 00763000356644 | BUR ENTMR8 1847B35LDC DMD CRS 3.5MM LNG |
| 00763000356637 | BUR ENTMR8 1847B40LDC DMD CRS 4MM LNG |
| 00763000356620 | BUR ENTMR8 1847B10SDC DMD CRS 1MM STD |
| 00763000356613 | BUR ENTMR8 1847B15SDC DMD CRS 1.5MM STD |
| 00763000356606 | BUR ENTMR8 1847B20SDC DMD CRS 2MM STD |
| 00763000356590 | BUR ENTMR8 1847B25SDC DMD CRS 2.5MM STD |
| 00763000356576 | BUR ENTMR8 1847B40SDC DMD CRS 4MM STD |
| 00763000356569 | BUR ENTMR8 1847B50SDC DMD CRS 5MM STD |
| 00763000355975 | BUR ENTMR8 1847B35SCT CUT 3.5MM STD |
| 00763000355968 | BUR ENTMR8 1847B40SCT CUT 4MM STD |
| 00763000356552 | BUR ENTMR8 1847B60SDC DMD CRS 6MM STD |
| 00763000356545 | BUR ENTMR8 1847B70SDC DMD CRS 7MM STD |
| 00763000356538 | BUR ENTMR8 1847B06LDM DMD MED 0.6MM LNG |
| 00763000356521 | BUR ENTMR8 1847B08LDM DMD MED 0.8MM LNG |
| 00763000356514 | BUR ENTMR8 1847B10LDM DMD MED 1MM LNG |
| 00763000356507 | BUR ENTMR8 1847B12LDM DMD MED 1.2MM LNG |
| 00763000356491 | BUR ENTMR8 1847B15LDM DMD MED 1.5MM LNG |
| 00763000356484 | BUR ENTMR8 1847B20LDM DMD MED 2MM LNG |
| 00763000356477 | BUR ENTMR8 1847B25LDM DMD MED 2.5MM LNG |
| 00763000356460 | BUR ENTMR8 1847B30LDM DMD MED 3MM LNG |
| 00763000356453 | BUR ENTMR8 1847B35LDM DMD MED 3.5MM LNG |
| 00763000356446 | BUR ENTMR8 1847B40LDM DMD MED 4MM LNG |
| 00763000356439 | BUR ENTMR8 1847B10SDM DMD MED 1MM STD |
| 00763000356422 | BUR ENTMR8 1847B15SDM DMD MED 1.5MM STD |
| 00763000356415 | BUR ENTMR8 1847B20SDM DMD MED 2MM STD |
| 00763000356408 | BUR ENTMR8 1847B25SDM DMD MED 2.5MM STD |
| 00763000356392 | BUR ENTMR8 1847B30SDM DMD MED 3MM STD |
| 00763000356385 | BUR ENTMR8 1847B35SDM DMD MED 3.5MM STD |
| 00763000356378 | BUR ENTMR8 1847B40SDM DMD MED 4MM STD |
| 00763000356323 | BUR ENTMR8 1847B10LDF DMD FINE 1MM LNG |
| 00763000356316 | BUR ENTMR8 1847B15LDF DMD FINE 1.5MM LNG |
| 00763000356309 | BUR ENTMR8 1847B20LDF DMD FINE 2MM LNG |
| 00763000356293 | BUR ENTMR8 1847B25LDF DMD FINE 2.5MM LNG |
| 00763000356286 | BUR ENTMR8 1847B30LDF DMD FINE 3MM LNG |
| 00763000356279 | BUR ENTMR8 1847B40LDF DMD FINE 4MM LNG |
| 00763000356262 | BUR ENTMR8 1847B50LDF DMD FINE 5MM LNG |
| 00763000356255 | BUR ENTMR8 1847B10SDF DMD FINE 1MM STD |
| 00763000356248 | BUR ENTMR8 1847B15SDF DMD FINE 1.5MM STD |
| 00763000356231 | BUR ENTMR8 1847B20SDF DMD FINE 2MM STD |
| 00763000356224 | BUR ENTMR8 1847B25SDF DMD FINE 2.5MM STD |
| 00763000356217 | BUR ENTMR8 1847B30SDF DMD FINE 3MM STD |
| 00763000356200 | BUR ENTMR8 1847B40SDF DMD FINE 4MM STD |
| 00763000356194 | BUR ENTMR8 1847B50SDF DMD FINE 5MM STD |