Terumo
Injection Filter Needle
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
Record
| Listed by | Terumo Europe NV |
|---|---|
| FDA product code | QYM |
| Device type | Ophthalmic Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| 510(k) | K230951 |
| Record published | 2023-10-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 30 °C; Special storage condition: Keep away from sunlight. Keep dry. |
| Packaging | Shelf box of 100, carton of 30 |
| Sizes | Needle gauge 30 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NF-3013RBKE05M | Needle Gauge 30 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| STERiJECT Ophthalmic Needle™ Low Dead Space (LDS) | TSK Laboratory International Japan K.K. | 6 |
| VitreJect Ophthalmic Needle | Ocuject, LLC | 4 |
| STERiJECT Ophthalmic Needle™ | TSK Laboratory International Japan K.K. | 2 |
| VitreJect-DL Ophthalmic Needle | Ocuject, LLC | 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.