FDA device listing
Urine Container, Urine Monovettes, Faeces Container, Tubes, Screw caps, CryoPure
FDA device listing 1359629047 · SARSTEDT AG & CO. KG
Key facts
| Proprietary names | Urine Container, Urine Monovettes, Faeces Container, Tubes, Screw caps, CryoPure |
|---|---|
| Owner/operator | SARSTEDT AG & CO. KG |
| Owner/operator number | 8010078 |
| Product codes | KDT |
| Device names | KDT - Container, Specimen Mailer And Storage, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | SARSTEDT AG & CO. KG, SARSTEDT, INC. |
| Establishment registrations | 2242368, 9617475 |
| FEI numbers | 2242368, 3002808075 |
| 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