InnoTherapy Inc.

Address:#1206-1210, ACE hightechcity 2,Seoul,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Dressing, Wound, Drug (FRO) (2)

Premarket Exempt

Clear

InnoSEAL Hemostatic Pad - 08800030700121 Catalog Number :

Device Description : InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local manag 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.

Device Class :

Duns Number: 688398443

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

InnoSEAL Hemostatic Pad - 08800030700138 Catalog Number :

Device Class : U

Duns Number: 688398443

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

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