| 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 |
| 08800020103536 - DENZA Main body | 2023-09-06 Radio-frequency skin contouring system |
| 08800020103918 - DENZA B-Tip II | 2023-09-06 DENZA B-Tip II |
| 08800020103925 - DENZA B-Tip | 2023-09-06 DENZA B-Tip |
| 08800020103932 - DENZA F-Tip II | 2023-09-06 DENZA F-Tip II |
| 08800020103949 - DENZA F-Tip | 2023-09-06 DENZA F-Tip |
| 08800020103956 - DENZA I-Tip II | 2023-09-06 DENZA I-Tip II |
| 08800020103963 - DENZA I-Tip | 2023-09-06 DENZA I-Tip |
| 08800020103970 - DENZA Handpiece | 2023-09-06 Radio-frequency skin contouring system |