Hemospray
Hemospray Endoscopic Hemostat
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Endoclot Plus Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | QAU |
| Device type | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4456 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-05-25 |
| Record revised | 2022-02-21 (version 4) |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G21049 | In distribution | |
| G56572 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexpowder | Nextbiomedical Co., Ltd. | 3 |
| PuraStat | 3-D Matrix Europe SAS | 2 |
| PuraStat (3mL) | 3-D Matrix, Ltd. | 1 |
| EndoClot | Endoclot Plus Co., Ltd. | 1 |
| PuraStat (1mL) | 3-D Matrix, Ltd. | 1 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Wilson-Cook Medical Inc. | UDI-DI | 2026-08-20 | Not classified | Labeling design | Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). | 121,241 units (U.S.-49240, O.U.S.-72001) |
| Wilson-Cook Medical Inc. | UDI-DI | 2024-08-29 | Class II | Nonconforming Material/Component | Specific lots of product have been manufactured with nonconforming raw materials. | UPDATE-4,605 devices |
| Wilson-Cook Medical Inc. | UDI-DI | 2023-05-22 | Class II | Under Investigation by firm | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope. | 63,830 units |
| Wilson-Cook Medical Inc. | UDI-DI | 2023-05-22 | Class II | Under Investigation by firm | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope. | 14,877 units |
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.