Vygon
Bone Marrow Procedure KIT
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
Record
| Listed by | Vygon Corp., United States |
|---|---|
| FDA product code | PXO |
| Device type | Bone Marrow Biopsy Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Record published | 2017-10-10 |
| Record revised | 2022-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 20, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMS-9008 | In distribution | |
| AMS-547 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 50 |
| Centurion | Centurion Medical Products Corporation | 7 |
| Medline | Medline Industries, Inc. | 7 |
| Bone Access Kit | Custom Interventional Pain Management | 3 |
| Stradis | Stradis Healthcare | 2 |
| Henry Schein | Henry Schein, Inc. | 2 |
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.