FDA device listing
LIFESTYLES KING GOLD/LIFESTYLES KYNG GOLD,LIFESTYLES LARGE,LIFESTYLES NYC KYNG,LIFESTYLES NYC LARGE,LIFESTYLES ULTRA…
FDA device listing 1553319256 · SURETEX, LTD.
Key facts
| Proprietary names | LIFESTYLES KING GOLD/LIFESTYLES KYNG GOLD,LIFESTYLES LARGE,LIFESTYLES NYC KYNG,LIFESTYLES NYC LARGE,LIFESTYLES ULTRA SENSITIVE PLATINUM LARGE,LIFESTYLES ULTRA SENSITIVE TITAN,MEGA RIDER |
|---|---|
| Owner/operator | SURETEX, LTD. |
| Owner/operator number | 9010022 |
| Premarket submissions | K001883 |
| Product codes | HIS, LTZ |
| Device names | HIS - Condom, LTZ - Condom With Nonoxynol-9 |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.5300, 884.5310 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | SURETEX, LTD. |
| Establishment registrations | 8040641 |
| FEI numbers | 3002808272 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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