| Primary Device ID | 00681490048941 |
| NIH Device Record Key | 43dc92df-1e19-438f-ab59-fcf6421d0e0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XPS® |
| Version Model Number | 1895410 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490048941 [Primary] |
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-05 |
| 00613994598301 | MICRODEBRIDER 1898200TRF IGS M4 REFURB |
| 00643169882836 | MICRODEBRIDER 1898200TLO LOANER M4 IGS |
| 00643169882799 | MICRODEBRIDER 1898200TRF IGS M4 REFURB |
| 00643169882706 | MICRODEBRIDER 1898200T IGS M4 ROHS |
| 00643169553019 | MICRODEBRIDER 1898200TLO LOANER M4 IGS |
| 00643169360846 | HANDPIECE 1897200 MAGNUM II EN ROHS |
| 00643169350663 | CONSOLE 1894440 MICRO MICRODEBRIDER ROHS |
| 00681490048941 | FOOTSWITCH 1895410 XPS SINGLE FUNCTION |
| 00681490048880 | FOOTSWITCH 1895400 XPS |