Tropocells®, Eclipse PRP, Healeon PRP
2 catalogue numbers from PPK3B, listed by Estar Technologies Ltd., Israel, under Platelet And Plasma Separator For Bone Graft Handling. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Beijing Hanbaihan Medical Devices Co., Ltd. | Beijing | Beijing | Contract manufacturer | 4 |
Record
| Listed by | Estar Technologies Ltd., Israel |
|---|---|
| FDA product code | ORG |
| Device type | Platelet And Plasma Separator For Bone Graft Handling |
| Device class | Class 2 |
| Regulation | 21 CFR 864.9245 |
| Establishment | Manufacturer |
| 510(k) | BK110035 |
| Record published | 2016-09-24 |
| Record revised | 2020-07-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PPK3B | In distribution | |
| 12531102GLVAS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 30 |
| Endoret KIT | Biotechnology Institute SL | 14 |
| Harvest® | Terumo BCT, Inc.. | 14 |
| IntraSpin | Intra-Lock International | 13 |
| Xcell | Apex Biologix | 13 |
| BioHorizons | Biohorizons Implant Systems Inc. | 11 |
| Celling ART PRP System | Celling Biosciences | 8 |
| Progen PRP Eclipse | Bellus Medical, LLC | 8 |
| Selphyl® | Factor Medical Inc. | 7 |
| Tropocells | Estar Technologies Ltd. | 7 |
| Virtue ACKit | Aeon Biotherapeutics Corp. | 7 |
| Aeon ACKit | Aeon Biotherapeutics Corp. | 6 |
Showing 12 of 119. All products under Platelet And Plasma Separator For Bone Graft Handling
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.