Qualtex, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Qualtex, Inc. makes
Qualtex, Inc. manufactures disposable surgical sponges for laparotomy procedures and skin markers used for preoperative patient identification or surgical site annotation.
The company’s products are classified as Class I and Unclassified (U) devices under FDA regulations and are listed in the FDA’s 510(k) registry. Qualtex, Inc. is based in the United States.
Catalogue
Laparotomy Sponge Ref K780818
Regimes: 510(k) Registry: 510(k)Qualtex Skin Marker Ref K904559
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Qualtex, Inc. have in the registry?
The registry currently lists 2 devices for Qualtex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qualtex, Inc.'s devices?
Among its 2 most recently registered devices, Qualtex, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Qualtex, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Qualtex, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Qualtex, Inc. in the registry?
The most recently registered devices listed for Qualtex, Inc. include LAPAROTOMY SPONGE and QUALTEX SKIN MARKER.