Embosphere®
24 catalogue numbers from 00884450098561, listed by Biosphere Medical, Inc., United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.
1manufacturer
24catalogue 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 | Biosphere Medical, 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 | 2015-10-30 |
| 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 |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450098561 | Size Range-100-300 µm | In distribution |
| 00884450116296 | Size Range-300-500 µm | In distribution |
| 00884450110621 | Size Range-100-300 µm | In distribution |
| 00884450299432 | Size Range-50-100 µm | In distribution |
| 00884450106051 | Size Range-700-900 µm | In distribution |
| 00884450089231 | Size Range-900-1200 µm | In distribution |
| 00884450089286 | Size Range-300-500 µm | In distribution |
| 00884450089279 | Size Range-500-700 µm | In distribution |
| 00884450089316 | Size Range-100-300 µm | In distribution |
| 00884450089293 | Size Range-300-500 µm | In distribution |
| 00884450089309 | Size Range-100-300 µm | In distribution |
| 00884450089323 | Size Range-40-120 µm | In distribution |
| 00884450089255 | Size Range-700-900 µm | In distribution |
| 00884450115169 | Size Range-900-1200 µm | In distribution |
| 00884450114223 | Size Range-40-120 µm | In distribution |
| 00884450109854 | Size Range-500-700 µm | In distribution |
| 00884450089248 | Size Range-700-900 µm | In distribution |
| 00884450116715 | Size Range-500-700 µm | In distribution |
| 00884450089224 | Size Range-900-1200 µm | In distribution |
| 00884450089330 | Size Range-40-120 µm | In distribution |
| 00884450089262 | Size Range-500-700 µm | In distribution |
| 00884450098424 | Size Range-300-500 µm | In distribution |
| 00884450104750 | Size Range-700-900 µm | In distribution |
| 00884450109519 | Size Range-900-1200 µm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K021397 | 2002-11-22 |
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.