Biom Ready Disposable for F=200 Mm
Catalogue number 54414, 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
1catalogue number
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 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54414 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SurgiTel | Surgitel | 65 |
| Biom Optic Set disposable, with Biom HD Professional lens for f=175 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 2 |
| 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 |
| 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.