Omega Mark-3 Pen Corp.
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- Devices
- 1
What Omega Mark-3 Pen Corp. makes
Omega Mark-3 Pen Corp. manufactures the Mark-3 Skin Marking Fountain pen, a disposable ink fountain pen designed for marking skin during medical procedures.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Pen, Mark-3 Skin Marking Fountain Ref K781694
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omega Mark-3 Pen Corp. have in the registry?
The registry currently lists 1 device for Omega Mark-3 Pen Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omega Mark-3 Pen Corp.'s devices?
Among its 1 most recently registered device, Omega Mark-3 Pen Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Omega Mark-3 Pen Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Omega Mark-3 Pen Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Omega Mark-3 Pen Corp. in the registry?
The most recently registered devices listed for Omega Mark-3 Pen Corp. include PEN, MARK-3 SKIN MARKING FOUNTAIN.