| Primary Device ID | 00613994422095 |
| NIH Device Record Key | a9131b58-f5cc-4c58-aeca-550d76459ec4 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | BM100-R |
| 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 | 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994422095 [Primary] |
| HBB | MOTOR, DRILL, PNEUMATIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994422095]
Moist Heat or Steam Sterilization
[00613994422095]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-26 |
| 00763000521622 - MIDAS REX MR8 | 2025-08-18 ATT MR8-ASDS01-R MR8 STR DPTH STP RFRB A^ |
| 00763000980849 - Reservoir | 2025-08-11 RESERVOIR 24106 A NEONT ANGULAR CATH 3CM |
| 00763000980856 - Reservoir | 2025-08-08 RES 22101 A NEO FLAT DOME W/ 3.0CM VCATH |
| 00763000722326 - ENT MR8 | 2025-08-04 TUBING ENTMR8 1847CVTUBEA CLEARVIEW EA |
| 00763000722340 - ENT MR8 | 2025-08-04 TUBING ENTMR8 1847IRTUBEA IRRIGATION EA |
| 00763000722364 - MIDAS REX MICROSAWS | 2025-08-04 TUBING IRD410 MICROSAW FOOT-CONTROLLED |
| 00763000722388 - MIDAS REX LEGEND | 2025-08-04 TUBING IRD450 EA IPC LOW PRO IRRIGATION |
| 00763000722319 - ENT MR8 | 2025-08-04 TUBING ENTMR8 1847CVTUBBX CLEARVIEW 5PK |