| Primary Device ID | 10817377023115 |
| NIH Device Record Key | 727dfe25-e219-487c-9032-3eed1a1fa07d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Electrodes |
| Version Model Number | 13-50000-0001 |
| Company DUNS | 079976463 |
| Company Name | DYMEDIX DIAGNOSTICS, 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 | true |
| 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 | 00817377023118 [Primary] |
| GS1 | 10817377023115 [Package] Contains: 00817377023118 Package: [10 Units] In Commercial Distribution |
| GS1 | 20817377023112 [Package] Contains: 00817377023118 Package: [50 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-14 |
| Device Publish Date | 2021-07-06 |
| 10817377021418 | Dual EMG Electrode |
| 10817377021401 | Chin Electrode Patch |
| 10817377021395 | Dual Snap Lead Wire, 60", 2 Pack |
| 10817377021388 | Dual Snap Lead Wire, 48", 2 Pack |
| 10817377021371 | Dual Snap Lead Wire, 120", 2 Pack |
| 10817377021364 | Dual Snap Lead Wire, 100", 2 Pack |
| 10817377023115 | XM Movement Sensor |
| 10817377023108 | Chin Electrode Patch Infant |
| 10817377022835 | Dual Wired EMG Electrode 60" |
| 10817377022828 | Dual Wired EMG Electrode 120" |