| Primary Device ID | 08800020103970 |
| NIH Device Record Key | a2f29898-d155-4d4f-8082-a1016cef9b36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DENZA Handpiece |
| Version Model Number | DENZA Handpiece |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800020103970 [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 |
| 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) |
| 08800020103536 - DENZA Main body | 2023-09-06 Radio-frequency skin contouring system |
| 08800020103918 - DENZA B-Tip II | 2023-09-06 DENZA B-Tip II |