VitreJect Ophthalmic Needle
4 catalogue numbers from PN0407-04, 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
4catalogue numbers in this listing
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, shipping box of 1000 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PN0407-04 | In distribution | |
| PN0407-01 | In distribution | |
| PN0404-03 | In distribution | |
| PN0407-03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| STERiJECT Ophthalmic Needle™ Low Dead Space (LDS) | TSK Laboratory International Japan K.K. | 6 |
| STERiJECT Ophthalmic Needle™ | TSK Laboratory International Japan K.K. | 2 |
| Terumo | Terumo Europe NV | 1 |
| 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.