| Primary Device ID | 00857869005215 |
| NIH Device Record Key | cdc7593d-5ac7-42b3-af9b-4bf5fbb2d7ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruDenta Electrodes |
| Version Model Number | TruDenta Electrodes |
| Company DUNS | 610954729 |
| Company Name | Electromedical Products International, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857869005215 [Primary] |
| GS1 | 10857869005212 [Package] Package: autobag [10 Units] In Commercial Distribution |
| GS1 | 20857869005219 [Package] Contains: 10857869005212 Package: case [30 Units] In Commercial Distribution |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-06-30 |
| 00857869005277 - Alpha-Stim Conducting Solution | 2021-12-08 Alpha-Stim Conducting Solution 50 ml |
| 00857869005284 - Alpha-Stim Conducting Solution | 2021-12-08 Alpha-Stim Conducting Solution 250 ml |
| 00857869005017 - Alpha-Stim AID | 2020-03-05 Alpha-Stim AID kit - China |
| 00857869005208 - Alpha-Stim SCS | 2020-03-05 Alpha-Stim SCS kit |
| 00857869005260 - Alpha-Stim AID | 2020-03-05 Alpha-Stim AID kit - US |
| 00857869005000 - Alpha-Stim M | 2019-05-23 Alpha-Stim M kit - China |
| 00857869005185 - Alpha-Stim PPM | 2019-05-23 Alpha-Stim PPM kit |
| 00857869005192 - Alpha-Stim 100 | 2019-05-23 Alpha-Stim 100 kit |