| Primary Device ID | 00860009982499 |
| NIH Device Record Key | 303bb617-e368-46f9-9a37-66e1230d5311 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zemits EndoLuxx |
| Version Model Number | 2 |
| Catalog Number | 113622 |
| Company DUNS | 043911204 |
| Company Name | Advance-Esthetic LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 | 00860009982499 [Primary] |
| ISA | Massager, Therapeutic, Electric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-25 |
| Device Publish Date | 2023-09-15 |
| 00860010841174 - Zemits DuoCratus | 2024-02-14 |
| 00860010841112 - Zemits Klein EL | 2024-02-05 |
| 00860010841129 - Zemits Klein RF | 2024-02-05 |
| 00860010841136 - Zemits Verstand HD | 2024-02-05 |
| 00860010841143 - Zemits JoliPeel | 2024-02-05 |
| 00860010841150 - Zemits CelluSpice Pro | 2024-02-05 |
| 00860010841167 - Zemits OxiVelour | 2024-02-05 |
| 00860009982413 - Zemits CrystalFrax | 2023-09-25 |