| Primary Device ID | 20868924000018 |
| NIH Device Record Key | 2fb830a0-e266-4999-a113-48a2a984cf5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Applicator Cover |
| Version Model Number | PVTC30 |
| Company DUNS | 018207519 |
| Company Name | Regenesis Biomedical, Inc. |
| Device Count | 30 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00868924000038 - Reprieve by Regenesis | 2023-08-31 The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wa |
| 00868924000021 - Provant Infinity | 2021-01-29 The device includes a Control Unit and Treatment Applicator. The Control Unit is enclosed in a UL-compliant injection-molded cas |
| 20868924000018 - Disposable Applicator Cover | 2018-03-29Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is |
| 20868924000018 - Disposable Applicator Cover | 2018-03-29 Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological conta |
| 00868924000007 - Provant Therapy System | 2018-03-29 The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-c |