The following data is part of a De Novo classification by with the FDA for .

Pre-market Notification Details

DeNovo IDDEN250009
Applicant

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00199284522503 DEN250009 000
00199284432970 DEN250009 000
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.