FDA device listing
Ultra Sample Kits
FDA device listing 1528061247 · Elevate Solutions Group, LLC
Key facts
| Proprietary names | Ultra Sample Kits |
|---|---|
| Owner/operator | Elevate Solutions Group, LLC |
| Owner/operator number | 10058417 |
| Premarket submissions | P170035 |
| Product codes | LPM |
| Device names | LPM - Lenses, Soft Contact, Extended Wear |
| Device class | Class III |
| Classification regulations (21 CFR) | 886.5925 |
| Review panels | Ophthalmic |
| Registered establishments | ELEVATE SOLUTIONS GROUP, LLC |
| Establishment registrations | 3015533540 |
| FEI numbers | 3015533540 |
| Establishment operations | Repackager/Relabeler |
| 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