| Primary Device ID | 08800020104304 |
| NIH Device Record Key | 283d3f3e-593c-4cce-9c17-c40d81314b63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Density Main body |
| Version Model Number | Density Main body |
| 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 | 08800020104304 [Primary] |
| GS1 | 08800020104311 [Package] Package: Wooden crate [1 Units] In Commercial Distribution |
| 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 |
| 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 |