K Number
K253609Device Name
TRAUMAGEL® 2.0 Hemostatic GelManufacturer
Date Cleared
2025-12-12
(24 days)
Product Code
Regulation Number
N/AType
SpecialReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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