Biom Optic Set Disposable, With Biom HD Professional Lens for F=175 Mm
2 catalogue numbers from 54411, listed by Oculus Optikgeräte Gesellschaft mit beschränkter Haftung, under Spectacle, Operating (Loupe), Ophthalmic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Hong Kong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Anco China Ltd | Hong Kong | Hong Kong | Exporter | 6 |
Record
| Listed by | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | HOH |
| Device type | Spectacle, Operating (Loupe), Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4770 |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
| Record revised | 2022-12-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -10 to 50 °C; Storage environment humidity 10 to 85 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54411 | In distribution | |
| 54412 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SurgiTel | Surgitel | 65 |
| HNM Medical | HNM Stainless, LLC. | 1 |
| Biom Optic Set disposable, with Biom HD Flex lens for f=175 mm or f=200 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Biom ready+ 175, for f=175 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Biom ready+ 200, for f=200 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Biom 6 HD Optic Set for f=175 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Biom ready disposable for f=200 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| EyeMag Classic | Carl Zeiss Meditec Inc | 1 |
| EyeMag Smart TTL | Carl Zeiss Meditec Inc | 1 |
| Biom 6 HD Optic Set for f=200 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| HD Disposable LenZ | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| EyeMag Pro S | Carl Zeiss Meditec Inc | 1 |
Showing 12 of 15. All products under Spectacle, Operating (Loupe), Ophthalmic
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.