| Primary Device ID | 00643169945395 |
| NIH Device Record Key | 8a88371d-45a1-40ba-93b4-fae6c3f5527b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 3152480 |
| 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 | 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 | 00643169945395 [Primary] |
| LTB | CYCLOSPORINE RADIOIMMUNOASSAY |
| 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 | 2017-10-16 |
| 00763000842543 - Bipolar Stimulating Probe | 2024-11-04 PROBE 8225351 5PK CONCEN BIPO STIM ROHS |
| 00763000842550 - Bipolar Stimulating Probe | 2024-11-04 PROBE 8225401 5PK SD-SD BIPOL STIM ROHS |
| 00763000842567 - Bipolar Stimulating Probe | 2024-11-04 PROBE 8225451 5PK PRASS BIPO STIMUL ROHS |
| 00763000891862 - ENT NIM Electrode | 2024-10-01 PROBE 8225275 BALL TIP 1MM ROHS |
| 00763000891879 - ENT NIM Electrode | 2024-10-01 PROBE 8225276 BALL TIP 2.3MM ROHS |
| 00763000580483 - ENT NIM Vital | 2024-09-27 CABLE 1352415 STIM DISSECTION 3M ROHS |
| 00763000578022 - N/A | 2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL |
| 00763000578039 - N/A | 2024-09-24 SPLINT 1528111 5PK EXTERNAL NASAL SMALL |