| Primary Device ID | 00613994865243 |
| NIH Device Record Key | 1a375d57-d842-41da-9773-610224fa2532 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | IRD410 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994865243 [Primary] |
| HBB | MOTOR, DRILL, PNEUMATIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-07-04 |
| 00763000930837 - MIDAS REX MR8 | 2024-10-11 TOOL MR8-9MH30P260 9CM MATCH 3MM P260MM |
| 00763000714482 - MR8 | 2024-08-27 TOOL MR8-10MH17L MR8 10CM MATCH 1.7MM L |
| 00763000714536 - MR8 | 2024-08-27 TOOL MR8-10BA80DC MR8 10CM BALL 8MM DC |
| 00763000753382 - ENT MR8 | 2024-06-17 UR 1847B20SCT ENTMR8 CUT 2MM STD |
| 00763000753412 - ENT MR8 | 2024-06-17 UR 1847B20SDM ENTMR8 DMD MED 2MM STD |
| 00763000714550 - MR8 Tools | 2024-05-06 TOOL MR8-14TD3030 MR8 TWIST DRL 3MMX30MM |
| 00763000732943 - MR8 | 2024-01-26 TOOL MR8-ND13BA30D MR8 13CM ND B D 3MM |
| 00763000732967 - MR8 | 2024-01-26 TOOL MR8-SD12BA30D MR8 12CM SD B D 3MM |