| Primary Device ID | 08800020103963 |
| NIH Device Record Key | ec870628-6c76-4e8f-afa4-edeb25f72d1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DENZA I-Tip |
| Version Model Number | DENZA I-Tip |
| 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 | false |
| 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 | 08800020103963 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-06 |
| Device Publish Date | 2023-08-29 |
| 08800020106759 - Jeisys Medical Inc. | 2025-09-05 DENSITY Noir Main body |
| 08800020106407 - Jeisys Medical Inc. | 2025-09-02 ALPHA Tip |
| 18800020105506 - POTENZA Tip | 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-25 Tip) |
| 18800020105612 - POTENZA Tip | 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-16 Tip) |
| 18800020105629 - POTENZA Tip | 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-49 Tip) |
| 18800020106299 - POTENZA Tip | 2025-05-27 POTENZA Tip (DDR Tip) |
| 08800020106308 - POTENZA Tip | 2025-05-27 POTENZA Tip (SFA Tip) |
| 18800020106312 - POTENZA Tip | 2025-05-27 POTENZA Tip (DIA Tip) |