SKINSTITCH CORP.

Address:56 Center St,Massena,NY,13662,US

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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

Bandage, Liquid (KMF) (2) Tissue Adhesive For The Topical Approximation Of Skin (MPN) (1)

Premarket Exempt

Clear

GluStitch® Twist - B439013 Catalog Number :

Device Description : GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive. GluStitch Twist Tissue Adhesive is intended for the topical closure of surgical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch Twist may be used in conjunction with, but not in place of, deep dermal stitches.

Device Class : 2

Duns Number: 825880623

Premarket Exempt : No

Product Code : MPN

Prescription Use : Yes

Device Count : 1

GluSeal®90 - B439023 Catalog Number : GLUSEAL(ST)

Device Description : GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, bur GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns and minor irritation of the the skin and help protect them from infection.

Device Class : 1

Duns Number: 825880623

Premarket Exempt : No

Product Code : KMF

Prescription Use : No

Device Count : 1

GluSeal®90 - B439033 Catalog Number : GLUSEAL0.5(ST)

Device Class : 1

Duns Number: 825880623

Premarket Exempt : No

Product Code : KMF

Prescription Use : No

Device Count : 1

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