FDA device listing
Dynarex Non-Adherent Pad - 17" x 24",Eikon Bib - 13 x 18 - Medical Blue,Eikon Bib - 13 x 18 - Medical Blue - Case of…
FDA device listing 1330272123 · Eikon Device Inc.
Key facts
| Proprietary names | Dynarex Non-Adherent Pad - 17" x 24",Eikon Bib - 13 x 18 - Medical Blue,Eikon Bib - 13 x 18 - Medical Blue - Case of 500,Eikon Bib - 13 x 18 - Studio Grey - Bag of 125,Eikon Bib - 13 x 18 - Studio Grey - Case of 500,Eikon Drape Sheet - 40 x 48,Eikon Drape Sheet - 40 x 48 - Studio Grey,Eikon Drape Sheet - 40 x 60 - Medical Blue,Eikon Drape Sheet - 40 x 60 - Studio Grey,Graham FlexAir Plus… |
|---|---|
| Owner/operator | Eikon Device Inc. |
| Owner/operator number | 10044469 |
| Product codes | KME |
| Device names | KME - Bedding, Disposable, Medical |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6060 |
| Review panels | General Hospital |
| Registered establishments | EIKON DEVICE INC. |
| Establishment registrations | 3010363542 |
| FEI numbers | 3010363542 |
| Establishment operations | Foreign Exporter |
| 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