The StaClear Model SC250LL Syringe is a single-use piston syringe consisting of a graduated barrel with luer lock connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and…
The StaClear Model SC250LL Syringe is a single-use piston syringe consisting of a graduated barrel with luer lock connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Model SC250LL Syringe is suitable for ophthalmic use.
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1).
Record
Regulatory record for StaClear | Listed by | Staclear, Inc., United States |
| FDA product code | QLY |
| Device type | Ophthalmic Syringe |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Manufacturer |
| 510(k) | K200242 |
| Record published | 2020-12-11 |
| Record revised | 2023-12-15 (version 5) |
Specifications
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 |
| Packaging | Case of 10, box of 100, case of 1000, bag of 20, convenience tray of 50, box of 2 |
| Sizes | Total volume 0.25 ml; needle gauge 31 G; length 8 mm |
| Distribution end date | 2023-09-01 |
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.