PosiSep C² devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C² devices were specifically engineered for use as a nasal dressing to be…
PosiSep C² devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C² devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
Who Else Makes It
Concentrated in Guangdong (4), Tianjin (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for PosiSep C | Listed by | Hemostasis, LLC, United States |
| FDA product code | EMX |
| Device type | Balloon, Epistaxis |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4100 |
| Establishment | Manufacturer |
| 510(k) | K122494 |
| Record published | 2020-02-20 |
| Record revised | 2025-01-20 (version 4) |
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 | Special storage condition: Store at room temperature |
| Packaging | Carton of 5 |
| Sizes | Width 1.27 cm; length 3.81 cm |
| UDI direct marking | Exempt |
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.