Catalogue number 1295.3, listed by D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands, under Cannula, Ophthalmic. 6 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Subretinal cannula, curved 20 gauge/0.9 mm needle with 0.3 mm tip. | Listed by | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands |
| FDA product code | HMX |
| Device type | Cannula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-02-11 |
| Record revised | 2026-01-23 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date |
| Distribution end date | 2024-05-30 |
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.