Arjo Wiggins Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Arjo Wiggins Medical, Inc. makes
Arjo Wiggins Medical, Inc. manufactures non-woven sterile barrier wraps designed for medical sterilization, including single-use sheets and rolls like SteriSheets, Arjowrap 47/100, Arjowrap 47/88, and Arjorad sterile wrap. These products are intended for packaging surgical instruments, implants, and other medical devices to maintain sterility during storage and transport.
The company’s sterile wraps are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they must comply with FDA requirements for sterile barrier systems. The manufacturer operates from its U.S. headquarters
Catalogue
Sterilization Wrap-Sterisheet Ref K931202
Regimes: 510(k) Registry: 510(k)Arjowrap 47/100 And 47/88 Ref K062100
Regimes: 510(k) Registry: 510(k)Arjorad Sterile Wrap Ref K110954
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Arjo Wiggins Medical, Inc. have in the registry?
The registry currently lists 3 devices for Arjo Wiggins Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arjo Wiggins Medical, Inc.'s devices?
Among its 3 most recently registered devices, Arjo Wiggins Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Arjo Wiggins Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Arjo Wiggins Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Arjo Wiggins Medical, Inc. in the registry?
The most recently registered devices listed for Arjo Wiggins Medical, Inc. include STERILIZATION WRAP-STERISHEET, ARJOWRAP 47/100 AND 47/88 and ARJORAD STERILE WRAP.