| Primary Device ID | B1870470 |
| NIH Device Record Key | b7162894-7184-497c-bfab-beb850e39984 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PDC Restorer |
| Version Model Number | PLB066-1080 |
| Company DUNS | 147018519 |
| Company Name | NEUROTRON MEDICAL, INC. |
| Device Count | 2 |
| 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 | false |
| 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 |
|---|---|
| HIBCC | B1870470 [Unit of Use] |
| HIBCC | B1870471 [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 | 2024-10-22 |
| Device Publish Date | 2024-10-14 |
| B1870620 | Electrolyte solution, 4 oz. spray bottle |
| B1870490 | Conductive duo-glove, dual polarity, 1/package |
| B1870480 | Conductive duo-sock, dual polarity, 1/package |
| B1870460 | Conductive sock (std.), single polarity, 1/package |
| B1870450 | Conductive glove, single polarity, 1/package |
| B1870740 | Conductive duo-elbow, dual polarity, 1/package |
| B1870760 | Conductive duo-sock, dual polarity, X-Large, 1/package |
| B1870770 | Conductive duo-knee, dual polarity, 1/package |
| B1870780 | Conductive pad, 3 in. x 5 in., 2/package |
| B1870790 | Conductive pad, 2 in. x 3 in., 2/package |
| B1870470 | Conductive pad, 1.5 in. x 8 in., 2/package |