Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids. Connects to Sonomed Escalon Viscous Fluid System, Trek VFI-10, Richard James FTS-50 and…
Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids. Connects to Sonomed Escalon Viscous Fluid System, Trek VFI-10, Richard James FTS-50 and FTS-100 systems, Greishaber VIS, and others. Pack includes 10cc syringe with pressure-tested tubing and adapters, stainless steel cannula, and Teflon cannula. 0.2 micron filter included to maintain sterile field. Sterile, single-use.
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Viscous Fluid Pack | Listed by | Escalon Medical Corp, United States |
| FDA product code | MRH |
| Device type | Pump, Infusion, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K963434 |
| Record published | 2016-01-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
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 |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Box of 10 |
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.