| Primary Device ID | 06970341677619 |
| NIH Device Record Key | 3267fa6c-1e46-4c7e-ae43-82529b5f2d13 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | NA |
| Company DUNS | 529401134 |
| Company Name | GMDASZ manufacturing Co., Ltd. |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970341670481 [Primary] |
| GS1 | 06970341674694 [Package] Contains: 06970341670481 Package: PE bag [10 Units] In Commercial Distribution |
| GS1 | 06970341674786 [Package] Contains: 06970341670481 Package: PE bag [25 Units] In Commercial Distribution |
| GS1 | 06970341677619 [Package] Contains: 06970341670481 Package: paper carton [1000 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| 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 | 2017-10-27 |
| 06970341670863 - NA | 2024-05-07 diameter 32mm |
| 06970341670870 - NA | 2024-05-07 diameter 50mm |
| 06970341670894 - NA | 2024-05-07 |
| 06970341673529 - NA | 2024-05-07 60X170mm |
| 6970341677084 - NA | 2018-07-06 Electrode pad, prewired, 1 pack of 4pcs, white cloth backing |
| 06970341677527 - NA | 2018-07-06 dual snap electrode, dia. 22mm |
| 06970341677510 - NA | 2018-07-06 dual snap electrode pad, dia. 18mm |
| 6970341677046 - NA | 2018-07-06 electrode pad, 50x50mm square, prewired, foam backing |