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510(k) Data Aggregation
K Number
K161013Device Name
InnoSEAL Hemostatic Pad
Manufacturer
Date Cleared
2016-11-29
(232 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
InnoTherapy Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
InnoSEAL Hemostatic Pad is intended for the local management of bleeding wounds and for the promotion of rapid control of bleeding. InnoSEAL Hemostatic Pad is intended for use under the care of a healthcare professional.
The dressing is indicated for following wounds; lacerations, abrasions and the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes.
Device Description
InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation.
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