Premier Guard USA, LLC
Country not established
- Devices
- 5
What Premier Guard USA, LLC makes
Premier Guard USA, LLC manufactures single-use, non-antimicrobial surgical and medical face masks designed for clinical and procedural settings. Their portfolio includes ASTM Level 2 and Level 3 masks, featuring ear-loop designs for patient and user convenience.
These devices are classified as Class II under FDA regulations and are authorised through 510(k) clearance and the FDA’s Unique Device Identifier (UDI) system. The company’s products are listed in the FDA’s regulatory databases, reflecting compliance with U.S. medical device standards.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 117537165
- [email protected]
- Phone
- 888-706-1231
Frequently asked questions
How many devices does Premier Guard USA, LLC have in the registry?
The registry currently lists 5 devices for Premier Guard USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Premier Guard USA, LLC's devices?
Among its 5 most recently registered devices, Premier Guard USA, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Premier Guard USA, LLC's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Premier Guard USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Premier Guard USA, LLC in the registry?
The most recently registered devices listed for Premier Guard USA, LLC include ASTM Level 2 Surgical Face Mask 20-1003-SFM2, ASTM Level 3 Surgical Face Mask 20-1002-SFM3, Face Mask 20-1001-FM and Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask.