| Primary Device ID | 20643169294350 |
| NIH Device Record Key | 2166c25f-8df6-4cb7-8517-df4e21419a6d |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8227515 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169294356 [Primary] |
| GS1 | 20643169294350 [Package] Contains: 00643169294356 Package: PK [5 Units] In Commercial Distribution |
| IKN | Electromyograph, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-22 |
| 00763000835323 - NIM Neuro | 2025-01-31 MAINFRAME 8253402 NEURO 3.0 INTL EL ROHS |
| 00763000835330 - NIM Neuro | 2025-01-31 PATIENT INTFC 8253410 NIM NEURO 3.0 ROHS |
| 00763000003036 - NIM Vital™ | 2024-11-15 CONN CABLE NIM4CPB2 PAT INTFC NIM 4.0 |
| 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 |