| Primary Device ID | 06970341673529 |
| NIH Device Record Key | 55b2b6a9-7028-49b2-899a-6d677d46795b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SBM1AN001 |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970341673529 [Primary] |
| 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 | 2024-05-07 |
| Device Publish Date | 2024-04-29 |
| 06970341670863 - NA | 2024-05-07 diameter 32mm |
| 06970341670870 - NA | 2024-05-07 diameter 50mm |
| 06970341670894 - NA | 2024-05-07 |
| 06970341673529 - NA | 2024-05-0760X170mm |
| 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 |