| Primary Device ID | 8800020103024 |
| NIH Device Record Key | 70d97f5b-7268-42aa-9189-830ee525204b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmoothCool |
| Version Model Number | SmoothCool |
| Company DUNS | 690275362 |
| Company Name | Jeisys Medical Inc. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 08800020103017 [Primary] |
| GS1 | 8800020103024 [Package] Contains: 08800020103017 Package: Wooden crate [1 Units] In Commercial Distribution |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-10-19 |
| Device Publish Date | 2016-10-05 |
| 08800020101525 - POTENZA | 2026-03-24 POTENZA Neutral Electrode Pad Cable |
| 08800020108166 - DENSITY | 2026-03-24 DENSITY_Foot switch |
| 08800020108173 - DENSITY | 2026-03-24 DENSITY Power cord |
| 08800020108180 - DENSITY | 2026-03-24 DENSITY Neutral Electrode Pad cable |
| 08800020108197 - DENSITY | 2026-03-24 DENSITY Handpiece holder |
| 08800020108203 - DENSITY | 2026-03-24 DENSITY Handpiece cradle |
| 08800020108289 - DENSITY Tip | 2026-03-24 DENSITY Tip_Classic-B Tip |
| 08800020108272 - DENSITY Tip | 2026-03-24 DENSITY Tip_Classic-E Tip |