| Primary Device ID | B243PSSA2X2PP4 |
| NIH Device Record Key | 91559b92-b51c-4233-a355-e1d16e421478 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Self-Adhesive Electrode 2" x 2" Pro Pulse HD |
| Version Model Number | 0 |
| Company DUNS | 160641309 |
| Company Name | ELECTRO MEDICAL TECHNOLOGIES, LLC |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B243PSSA2X2PP4 [Primary] |
| 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 | 2016-09-23 |
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| B243PSSA2X2PP4 - Self-Adhesive Electrode 2" x 2" Pro Pulse HD | 2018-07-06 Self-Adhesive Electrode |