Gorbec Pharmaceutical Services, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Gorbec Pharmaceutical Services, Inc. makes
Gorbec Pharmaceutical Services, Inc. manufactures the BARIREP, a medical device designed for radiographic contrast enhancement, and the ZENIEVA, a system for intravenous contrast administration. The company also provides modifications to the ZENIEVA device to adapt its functionality or specifications.
The BARIREP and ZENIEVA devices are regulated under FDA’s 510(k) pathway, classified as Class I and Unclassified (U). These devices are listed in the FDA’s 510(k) database, reflecting their regulatory clearance status. The company is based in the United States.
Catalogue
Barirep Ref K100839
Regimes: 510(k) Registry: 510(k)Zenieva Ref K073246
Regimes: 510(k) Registry: 510(k)Modification To Zenieva Ref K082865
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gorbec Pharmaceutical Services, Inc. have in the registry?
The registry currently lists 3 devices for Gorbec Pharmaceutical Services, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gorbec Pharmaceutical Services, Inc.'s devices?
Among its 3 most recently registered devices, Gorbec Pharmaceutical Services, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Gorbec Pharmaceutical Services, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gorbec Pharmaceutical Services, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Gorbec Pharmaceutical Services, Inc. in the registry?
The most recently registered devices listed for Gorbec Pharmaceutical Services, Inc. include BARIREP, ZENIEVA and MODIFICATION TO ZENIEVA.