Sierra Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
What Sierra Laboratories, Inc. makes
Sierra Laboratories, Inc. manufactures reusable and disposable male external catheters, including self-adhering and reusable models, as well as urinals and leg bags for urinary drainage. Their product line also includes skin staple extractors and a reusable leg bag system designed for incontinence management. The company produces specialized urinary accessories such as cone catheters and adhesive-based external catheter systems.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. Products are listed under U.S. jurisdiction, adhering to applicable medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Sierra Laboratories, Inc. have in the registry?
The registry currently lists 12 devices for Sierra Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sierra Laboratories, Inc.'s devices?
Among its 12 most recently registered devices, Sierra Laboratories, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Sierra Laboratories, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Sierra Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sierra Laboratories, Inc. in the registry?
The most recently registered devices listed for Sierra Laboratories, Inc. include URO TEX URINALS, MODEL 820 TOP=TRAK, COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER and URO-TEX MALE EXTERNAL CATHETER.