FDA device listing
Dittel Sound,Lefort Urethral Sounds,Sims Sounds,Urethral Sounds,Uterine Sound,Van Buren Sound
FDA device listing 1527249490 · GARANA INDUSTRIES
Key facts
| Proprietary names | Dittel Sound,Lefort Urethral Sounds,Sims Sounds,Urethral Sounds,Uterine Sound,Van Buren Sound |
|---|---|
| Owner/operator | GARANA INDUSTRIES |
| Owner/operator number | 9008379 |
| Product codes | HHM |
| Device names | HHM - Sound, Uterine |
| Device class | Class I |
| Classification regulations (21 CFR) | 884.4530 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | Garana Industries Private Limited |
| Establishment registrations | 3003759558 |
| FEI numbers | 3003759558 |
| Establishment operations | Contract Manufacturer, 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