Medline
Bone Marrow Biopsy/Aspirate Prep Tray
1manufacturer
7catalogue 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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | PXO |
| Device type | Bone Marrow Biopsy Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2021-06-14 |
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 |
| Packaging | Case of 20, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNDH1638 | In distribution | |
| DYNDH1596 | In distribution | |
| DYNDH1376A | In distribution | |
| TRIBT180A | In distribution | |
| DYNDH1514 | In distribution | |
| DYNDH1624 | In distribution | |
| DYNDH1625 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 50 |
| Centurion | Centurion Medical Products Corporation | 7 |
| Bone Access Kit | Custom Interventional Pain Management | 3 |
| Stradis | Stradis Healthcare | 2 |
| Vygon | Vygon Corp. | 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.