Texas Medplast, LLC
Country not established
- Devices
- 3
What Texas Medplast, LLC makes
Texas Medplast, LLC manufactures single-use, non-antimicrobial surgical face masks designed for medical and surgical settings. Their primary product, the Savvy Mask® Level 3, is intended for use in procedures requiring barrier protection against fluid exposure.
The company’s products are regulated as Class II devices in the US and are listed under FDA 510(k) and FDA UDI registries. The manufacturer operates from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
Savvy Mask - Level 3 Surgical Face Mask Ref K213406
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 117718048
Frequently asked questions
How many devices does Texas Medplast, LLC have in the registry?
The registry currently lists 3 devices for Texas Medplast, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Texas Medplast, LLC's devices?
Among its 3 most recently registered devices, Texas Medplast, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Texas Medplast, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Texas Medplast, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Texas Medplast, LLC in the registry?
The most recently registered devices listed for Texas Medplast, LLC include Savvy Mask® Level 3 Surgical Face Mask SM03, Savvy Mask® Level 3 Surgical Face Mask SM01 and Savvy Mask - Level 3 Surgical Face Mask.