Cook
Polyvinyl Alcohol (PVA) Foam Particles
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | NAJ |
| Device type | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-24 |
| Record revised | 2021-02-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| 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 |
|---|---|---|
| G09665 | In distribution | |
| G09664 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Embosphere® | Biosphere Medical, Inc. | 24 |
| Embozene Microspheres (Opaque) | Celonova Biosciences, Inc. | 20 |
| Embozene Microspheres (Color-Advanced) | Celonova Biosciences, Inc. | 20 |
| Contour™ | Boston Scientific Corporation | 14 |
| HydroPearl | MicroVention, Inc. | 12 |
| Bearing nsPVA® | Merit Medical Systems, Inc. | 7 |
| Embozene Color Advance 700um Embozene 1mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 900um Embozene 1mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 500um Embozene 2mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 250um Embozene 2mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 250um Embozene 1mL Colored – US | Varian Medical Systems, Inc | 1 |
| Embozene Color Advance 1300um Embozene 1mL Colored – US | Varian Medical Systems, Inc | 1 |
Showing 12 of 18. All products under Agents, Embolic, For Treatment Of Uterine Fibroids
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K081768 | 2008-12-23 |
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.