Arthrex®
Angel System w/ Pwr Aspiration Kit wACDA
2manufacturers in China registered for this device type
30catalogue 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 | Arthrex, 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, Manufacturer, Exporter |
| Record published | 2020-04-10 |
| Record revised | 2020-07-23 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ABS-10011T | In distribution | |
| ABS-10062K-TH13CTA | In distribution | |
| ABS-10013-B | In distribution | |
| ABS-2016-02 | In distribution | |
| ABS-10062D | In distribution | |
| ABS-10013-E | In distribution | |
| ABS-2016-03 | In distribution | |
| ABS-10061T | In distribution | |
| ABS-10060R | In distribution | |
| ABS-10062K-TH13OTA | In distribution | |
| ABS-10063 | In distribution | |
| ABS-2016-05 | In distribution | |
| ABS-10062K-TH8OT | In distribution | |
| ABS-10061 | In distribution | |
| ABS-10011 | In distribution | |
| ABS-10062CDN | In distribution | |
| ABS-10062K-TH8OTA | In distribution | |
| ABS-10067 | In distribution | |
| ABS-10060 | In distribution | |
| ABS-2016-04 | In distribution | |
| ABS-10015 | In distribution | |
| ABS-10062K-TH8CT | In distribution | |
| ABS-10013 | In distribution | |
| ABS-10062K-TH8CTA | In distribution | |
| ABS-10080 | In distribution | |
| ABS-10062K-TH13OT | In distribution | |
| ABS-10062T | In distribution | |
| ABS-2016-01 | In distribution | |
| ABS-10062 | In distribution | |
| ABS-10062K-TH13CT | In distribution |
Same Product Code
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|---|---|---|
| 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 |
| 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.