Steripak, Ltd.
Country not established
- Devices
- 2
What Steripak, Ltd. makes
Steripak, Ltd. manufactures sterile saline solutions for medical use, including a 20 mL topical topical solution of 0.9% sodium chloride and a 3 mL inhalation solution of 0.9% sodium chloride in USP-grade formulation.
These products are regulated as Class II and unclassified devices under FDA 510(k) requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Steripak, Ltd. have in the registry?
The registry currently lists 2 devices for Steripak, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Steripak, Ltd.'s devices?
Among its 2 most recently registered devices, Steripak, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Steripak, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Steripak, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Steripak, Ltd. in the registry?
The most recently registered devices listed for Steripak, Ltd. include 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE and 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP.