FDA device listing
30000-10 SOS Shikani Optical Stylet, Adult,30000-GLMM Mercury Medical Air-Vu Stylet,30000-GLMMPLUS Mercury Medical…
FDA device listing 1540746975 · CLARUS MEDICAL, LLC.
Key facts
| Proprietary names | 30000-10 SOS Shikani Optical Stylet, Adult,30000-GLMM Mercury Medical Air-Vu Stylet,30000-GLMMPLUS Mercury Medical Air-Vu Plus Stylet,30000-GLS Levitan FPS Scope,30000-GL SOS Shikani Greenline stylet,30001-10 SOS Shikani Optical Stylet, Pediatric,30003-P Pocket Scope |
|---|---|
| Owner/operator | CLARUS MEDICAL, LLC. |
| Owner/operator number | 9000372 |
| Premarket submissions | K962255 |
| Product codes | EOB |
| Device names | EOB - Nasopharyngoscope (Flexible Or Rigid) |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.4760 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | CLARUS MEDICAL, LLC. |
| Establishment registrations | 2183911 |
| FEI numbers | 1000116142 |
| Establishment operations | Manufacturer |
| 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