Embozene Microspheres (Opaque)
20 catalogue numbers from 19020-S0, listed by Celonova Biosciences, Inc., United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.
1manufacturer
20catalogue 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 | Celonova Biosciences, 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 |
| Record published | 2015-07-15 |
| Record revised | 2021-02-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 40 to 1300 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19020-S0 | Outer Diameter 900 µm | In distribution |
| 10710-S0 | Outer Diameter 75 µm | In distribution |
| 10420-S0 | Outer Diameter 40 µm | In distribution |
| 14020-S0 | Outer Diameter 400 µm | In distribution |
| 11020-S0 | Outer Diameter 100 µm | In distribution |
| 15010-S0 | Outer Diameter 500 µm | In distribution |
| 17020-S0 | Outer Diameter 700 µm | In distribution |
| 10410-S0 | Outer Diameter 40 µm | In distribution |
| 12010-S0 | Outer Diameter 250 µm | In distribution |
| 14010-S0 | Outer Diameter 400 µm | In distribution |
| 17010-S0 | Outer Diameter 700 µm | In distribution |
| 12020-S0 | Outer Diameter 250 µm | In distribution |
| 15020-S0 | Outer Diameter 500 µm | In distribution |
| 111010-S0 | Outer Diameter 1100 µm | In distribution |
| 10720-S0 | Outer Diameter 75 µm | In distribution |
| 11010-S0 | Outer Diameter 100 µm | In distribution |
| 19010-S0 | Outer Diameter 900 µm | In distribution |
| 113020-S0 | Outer Diameter 1300 µm | In distribution |
| 113010-S0 | Outer Diameter 1300 µm | In distribution |
| 111020-S0 | Outer Diameter 1100 µm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Embosphere® | Biosphere Medical, Inc. | 24 |
| Embozene Microspheres (Color-Advanced) | Celonova Biosciences, Inc. | 20 |
| Contour™ | Boston Scientific Corporation | 14 |
| HydroPearl | MicroVention, Inc. | 12 |
| Bearing nsPVA® | Merit Medical Systems, Inc. | 7 |
| 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 |
|---|---|
| K133447 | 2014-02-24 |
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.