PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic…
PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding. PuraStat is also indicated for the symptomatic management of Rectal Mucositis (RM), such as radiation proctitis that may be caused by chemotherapy or radiotherapy. (3 mL)
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for PuraStat (3mL) | Listed by | 3-D Matrix, Ltd., Japan |
| FDA product code | QAU |
| Device type | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4456 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2023-08-28 |
| Record revised | 2026-05-18 (version 2) |
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 |
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.