FDA device listing
DEXTACK,Medline / CDS orthopedic tray (kit),Medline UNITE
FDA device listing 1874683364 · Medline Industries, LP
Key facts
| Proprietary names | DEXTACK,Medline / CDS orthopedic tray (kit),Medline UNITE |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | OJH |
| Device names | OJH - Orthopedic Tray |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Medline Canada, MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, MEDLINE INDUSTRIES, LP - SPT, Medline Soluciones Medicas, Nuevo Laredo Directo al Cliente, PRODUCTOS MEDLINE S.A. DE C.V. |
| Establishment registrations | 1417592, 1423395, 3004122598, 3005595283, 3007289408, 3015173212, 3045816902, 3045816907 |
| FEI numbers | 1417592, 3000717925, 3004122598, 3005595283, 3007289408, 3015173212, 3045816902, 3045816907 |
| Establishment operations | Contract Sterilizer, Foreign Exporter, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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