CHEMENCE MEDICAL PRODUCTS, INC.

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Filters

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

Cutaneous Tissue Adhesive With Mesh (OMD) (2) Solvent, Adhesive Tape (KOX) (2) Tissue Adhesive For The Topical Approximation Of Skin (MPN) (2) Bandage, Liquid, Skin Protectant (NEC) (1)

Premarket Exempt

No Yes

Clear

GluGone Adhesive Remover, 4 oz. - 00854137001726 Catalog Number : GG80412

Device Description : 4 OZ

Device Class : 1

Duns Number: 079163089

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

GluGone Adhesive Remover, 0.67 oz. - 00854137001733 Catalog Number : GG80148

Device Description : 0.67 OZ

Device Class : 1

Duns Number: 079163089

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

LiquidSkin, 0.5g - 00854137001740 Catalog Number : 503 5000

Device Class : 1

Duns Number: 079163089

Premarket Exempt : Yes

Product Code : NEC

Prescription Use : No

Device Count : 1

exofin Fusion Skin Closure System SourceMark, 60cm - 00854137001757 Catalog Number : M1244

Device Class : 2

Duns Number: 079163089

Premarket Exempt : No

Product Code : OMD

Prescription Use : Yes

Device Count : 1

Exofin Fusion Skin Closure System SourceMark, 6cm - 00854137001801 Catalog Number : M1266

Device Class : 2

Duns Number: 079163089

Premarket Exempt : No

Product Code : OMD

Prescription Use : Yes

Device Count : 1

exofin HVTA ST&G, 1g Box of 10 - 20854137001140 Catalog Number : EX70407

Device Description : exofin HVTA ST&G, 1g Box of 10

Device Class : 2

Duns Number: 079163089

Premarket Exempt : No

Product Code : MPN

Prescription Use : Yes

Device Count : 1

exofin HVTSA, 1g- Box of 60 - 20854137001621 Catalog Number : EX70410

Device Description : High Viscosity Topical Skin Adhesive, Case

Device Class : 2

Duns Number: 079163089

Premarket Exempt : No

Product Code : MPN

Prescription Use : Yes

Device Count : 1

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