Bearing nsPVA®
7 catalogue numbers from 00884450123362, listed by Merit Medical Systems, Inc., United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.
1manufacturer
7catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Merit Medical Systems, Inc., 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-31 |
| Record revised | 2025-05-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450123362 | Size Range-710-1000 µm | In distribution |
| 00884450123331 | Size Range-250-355 µm | In distribution |
| 00884450123324 | Size Range-150-250 µm | In distribution |
| 00884450123348 | Size Range-355-500 µm | In distribution |
| 00884450123355 | Size Range-500-710 µm | In distribution |
| 00884450123317 | Size Range-45-150 µm | In distribution |
| 00884450123379 | Size Range-1000-1180 µm | 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 |
| Cook | Cook Incorporated | 2 |
| 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 |
|---|---|
| K233813 | 2023-12-21 |
| K130259 | 2013-06-07 |
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.