FDA device listing
Transcervical Contraceptive Tubal Occlusion Device
FDA device listing 1802181199 · Bayer Pharma, AG
Key facts
| Owner/operator | Bayer Pharma, AG |
|---|---|
| Owner/operator number | 10045903 |
| Premarket submissions | P020014 |
| Product codes | HHS |
| Device names | HHS - Transcervical Contraceptive Tubal Occlusion Device |
| Device class | Class III |
| Classification regulations (21 CFR) | 884.5380 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | Bayer HealthCare, LLC, BAYER PHARMA, AG |
| Establishment registrations | 2243252, 3002808086 |
| FEI numbers | 2243252, 3002808086 |
| Establishment operations | Complaint File Establishment, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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