FDA device listing
321236-Sterile Biospy CSTM,Medline / CDS biopsy tray or kit,Medline Lumbar Puncture Tray
FDA device listing 2021737360 · Medline Industries, LP
Key facts
| Proprietary names | 321236-Sterile Biospy CSTM,Medline / CDS biopsy tray or kit,Medline Lumbar Puncture Tray |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | FCH |
| Device names | FCH - Tray, Biopsy, Without Biopsy Instruments |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.4730 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - SPT, Medline Soluciones Medicas, Nuevo Laredo Directo al Cliente, PRODUCTOS MEDLINE S.A. DE C.V. |
| Establishment registrations | 1423395, 3004122598, 3005595283, 3015173212, 3045816902, 3045816907 |
| FEI numbers | 3000717925, 3004122598, 3005595283, 3015173212, 3045816902, 3045816907 |
| Establishment operations | Contract Sterilizer, Manufacturer, Repackager/Relabeler |
| 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