| Primary Device ID | 18800020101218 |
| NIH Device Record Key | 27ab6813-32c8-4e50-8978-46f431d72a8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTRAgen Tip |
| Version Model Number | KT-15 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 08800020101211 [Primary] |
| GS1 | 18800020101218 [Package] Contains: 08800020101211 Package: CARTON BOX [10 Units] In Commercial Distribution |
| OUH | Skin Resurfacing Rf Applicator |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-06 |
| Device Publish Date | 2022-03-29 |
| 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 |