Harvest®
Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-120n PRP Procedure Pack
2manufacturers in China registered for this device type
14catalogue 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 | Terumo BCT, Inc.., United States |
|---|---|
| FDA product code | ORG |
| Device type | Platelet And Plasma Separator For Bone Graft Handling |
| Device class | Class 2 |
| Regulation | 21 CFR 864.9245 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-15 |
| Record revised | 2024-02-08 (version 12) |
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 |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Pack of 6, pack of 2, pack of 4, pack of 3 |
| Distribution end date | 2023-11-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 51403 | Withdrawn | |
| 51404 | Withdrawn | |
| 51409 | Withdrawn | |
| 51401 | Withdrawn | |
| 51414 | Withdrawn | |
| 51410 | Withdrawn | |
| 51407 | Withdrawn | |
| 51402 | Withdrawn | |
| 51436 | Withdrawn | |
| 51408 | Withdrawn | |
| 51400 | Withdrawn | |
| 51406 | Withdrawn | |
| 51415 | Withdrawn | |
| 51405 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 30 |
| Endoret KIT | Biotechnology Institute SL | 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 |
| Fibrinet | Royal Biologics, Inc. | 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.