VitreJect-DL Ophthalmic Needle
Catalogue number PN0625-03, listed by Ocuject, LLC, United States, under Ophthalmic Needle. 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 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 | Ocuject, LLC, United States |
|---|---|
| FDA product code | QYM |
| Device type | Ophthalmic Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K242956 |
| Record published | 2025-02-28 |
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 |
| Packaging | Inner pack of 100, shipping box of 5000 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PN0625-03 | 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 |
| Terumo | Terumo Europe NV | 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.