Goulter Medical, Inc.
Country not established
- Devices
- 1
What Goulter Medical, Inc. makes
Goulter Medical, Inc. manufactures the ZIP Condom Catheter, a urinary drainage device designed for external catheterization, typically used by individuals with urinary retention or incontinence.
The ZIP Condom Catheter is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Zip Condom Catheter Ref K964219
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Goulter Medical, Inc. have in the registry?
The registry currently lists 1 device for Goulter Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Goulter Medical, Inc.'s devices?
Among its 1 most recently registered device, Goulter Medical, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Goulter Medical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Goulter Medical, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Goulter Medical, Inc. in the registry?
The most recently registered devices listed for Goulter Medical, Inc. include ZIP CONDOM CATHETER.