FDA device listing
Rael Micro Thin Organic Cotton Cover Daily Liners - Regular,Rael Organic Cotton Cover Pads - Extra Long Overnight,Rael…
FDA device listing 1192518367 · Rael, Inc.
Key facts
| Proprietary names | Rael Micro Thin Organic Cotton Cover Daily Liners - Regular,Rael Organic Cotton Cover Pads - Extra Long Overnight,Rael Organic Cotton Cover Panty Liners Extra Long,Rael Organic Cotton Cover Period Underwear L-XL,Rael Organic Cotton Cover Period Underwear S-M,Rael organic cotton pads - Large,Rael organic cotton pads - Overnight,Rael organic cotton pads - Petite,Rael organic cotton pads… |
|---|---|
| Owner/operator | Rael, Inc. |
| Owner/operator number | 10053897 |
| Product codes | HHD |
| Device names | HHD - Pad, Menstrual, Unscented |
| Device class | Class I |
| Classification regulations (21 CFR) | 884.5435 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | Rael, Inc. |
| Establishment registrations | 3013354376 |
| FEI numbers | 3013354376 |
| Establishment operations | Repackager/Relabeler |
| 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