Firefly
Digital Iris Scope
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
Record
| Listed by | Firefly Global, United States |
|---|---|
| FDA product code | HRB |
| Device type | Microscope, Operating, Non-Electric, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DE408 | In distribution | |
| DE400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.