Xcell
XCELL Platelet Concentrating System 60mL Convenience Kit (PN 90-018) created for Bioventus incorporating XC-PRP-60 (PN 90-001) and ACD-A (PN 70-111) This is a non-sterile configuration
2manufacturers in China registered for this device type
13catalogue 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 | Apex Biologix, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-10 |
| Record revised | 2021-03-11 (version 3) |
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, manufacturing date |
| Storage | Special storage condition: Store at room temp, avoid freezing and excessive heat |
| Packaging | Case of 10, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACD-A-13 | In distribution | |
| XC-PRP-60 | In distribution | |
| XC-RV-BDK1 | In distribution | |
| XC-PRP-60 Supplemental | In distribution | |
| XC-RV-60 RegenVET | In distribution | |
| XC-PRP-BV-60NS | In distribution | |
| XC-PC-60 | In distribution | |
| XC-PRP-BV-60 | In distribution | |
| ACD-A-20 | In distribution | |
| XC-PRP-BV-60EV | In distribution | |
| XC-PRP-BDK1 | In distribution | |
| XC-PRP-30 | In distribution | |
| XC-PC-120 | 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 |
| 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.