FDA device listing
Bone-HarvestOR - Autologous bone harvesting system,Cell-HarvestOR - Multiradial selective harvesting system of…
FDA device listing 1154082782 · M.D.L. S.r.l.
Key facts
| Proprietary names | Bone-HarvestOR - Autologous bone harvesting system,Cell-HarvestOR - Multiradial selective harvesting system of autologous bone marrow,HARVEST Disposable biopsy needle for bone marrow transplantation with "T" handle XXGxYYYmm,ILLY Disposable needle for iliac crest marrow aspiration, "T" handle XXGxYY/ZZmm,JAMBLU Bone marrow biopsy needle light version with extraction wire XXGxYYYmm,OSTEOJ… |
|---|---|
| Owner/operator | M.D.L. S.r.l. |
| Owner/operator number | 10047695 |
| Product codes | DWO |
| Device names | DWO - Needle, Biopsy, Cardiovascular |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | M.D.L. S.R.L. |
| Establishment registrations | 3004749705 |
| FEI numbers | 3004749705 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database