| Primary Device ID | 00628693343107 |
| NIH Device Record Key | 97bc67ba-872c-4bd7-aa62-3ac9d906aed2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amoils Epithelial Scrubber |
| Version Model Number | Amoils Power Handle, Neck & Charger - Kit (230V) |
| Catalog Number | AM1EXPH1 |
| Company DUNS | 249464702 |
| Company Name | Innova Medical Ophthalmics 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 00628693343107 [Primary] |
| HOG | Burr, Corneal, Battery-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-08 |
| Device Publish Date | 2024-10-31 |
| 00628693343053 | Amoils Epithelial Scrubber - Hyperopic XL Pack of 25 |
| 00628693343046 | Amoils Epithelial Scrubber - Hyperopic Pack of 25 |
| 00628693343039 | Amoils Epithelial Scrubber - Myopic Pack of 25 |
| 00628693343107 | Amoils Power Handle, Neck & Charger - Kit (230V) |
| 00628693343091 | Amoils Power Handle, Neck & Charger - Kit (120V) |
| 00628693343268 | Amoils Handle Charger (230V) |
| 00628693343251 | Amoils Handle Charger (120V) |
| 00628693343244 | Amoils Neck Mount |
| 00628693343237 | Amoils Power Handle |