| Primary Device ID | 80813520010345 |
| NIH Device Record Key | 3b1189ac-2e0a-42ce-918e-32954756df85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | E1P2020WC2 |
| Company DUNS | 022542271 |
| Company Name | Roscoe Medical |
| Device Count | 4 |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813520010349 [Primary] |
| GS1 | 01813520010348 [Unit of Use] |
| GS1 | 30813520010340 [Package] Contains: 00813520010349 Package: PK [50 Units] In Commercial Distribution |
| GS1 | 80813520010345 [Package] Contains: 30813520010340 Package: CA [8 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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-17 |
| 80813520011939 | InTENSity 10 Digital TENS |
| 80813520010772 | TENS 3000 Analog |
| 80813520010468 | Electrode - Foil - 2x2 - White |
| 01813520010430 | Electrode - Foil - 2 - White |
| 80813520010345 | K120 Electrode, Poly Bag 2 x |
| 00813520010042 | Electrode - Foil - 2 - Tan |
| 80813520010024 | Tan Cloth Electrodes w/ Tyco |
| 80092237616440 | 5cm Sound Head - 2nd Gen |
| 80092237618239 | Leadwire |
| 00092237618226 | SoundCare Plus - Wand, 5 cm |
| 00092237618219 | SoundCare Plus - Wand, 1 cm |
| 80092237617515 | InTENSity Twin Stim |
| 01092237617389 | CX4 & EX4 Clinical Leadwires |
| 80092237617379 | 78 Single (Combination) Lead |
| 01092237617365 | 78 Clinical Lead Wires |
| 80092237617348 | Lead Wires for Quattro 2/2.5 & |
| 80092237616761 | TwinStim Plus 2nd Edition |
| 80092237616754 | Twin Stim 2nd - TENS/EMS |
| 80092237616747 | SoundCare Plus - Professional |
| 80092237616709 | InTENSity Select Combo - |
| 80092237616686 | InTENSity IF Combo (TENS/IF) |
| 80092237616655 | EMS 7500 2nd Gen - Digital EMS |
| 80092237616433 | 1cm Sound Head - 2nd Gen |
| 80092237611629 | Quattro 2.5 |
| 80092237605468 | ComboCare E-Stim and |
| 80092237617386 | CX4 & EX4 Clinical Leadwires |
| 80092237617362 | 78 Clinical Lead Wires |