Scar Heal

Scar Heal

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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

Elastomer, Silicone, For Scar Management (MDA) (10)

Premarket Exempt

Yes

Clear

Scar Fx - 00642790100005 Catalog Number : 10000

Device Description : Scar Fx Silicone Sheeting 3" Breast Circle

Device Class :

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Scar Fx - 00642790101125 Catalog Number : 10112

Device Description : Scar Fx Silicone Sheeting 1"x12"

Device Class :

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Scar Fx - 00642790101224 Catalog Number : 10122

Device Description : Scar Fx Silicone Sheeting 1"x22"

Device Class :

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Scar Fx - 00642790103051 Catalog Number : 10305

Device Description : Scar Fx Silicone Sheeting 3"x5"

Device Class :

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Scar Fx - 00642790104089 Catalog Number : 10408

Device Description : Scar Fx Silicone Sheeting 4"x8"

Device Class :

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Scar Fx - 00642790106489 Catalog Number : 10648

Device Description : Gelzone garment belt with silicone sheeting 6"x48"

Device Class : 1

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Scar Fx - 00642790110127 Catalog Number : 11012

Device Description : Scar Fx Silicone Sheeting 10"x12"

Device Class : 1

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Scar Fx - 00642790112343 Catalog Number : 11234

Device Description : Scar Fx Silicone Sheeting Breast Piece

Device Class :

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Scar Fx - 00642790115030 Catalog Number : 11503

Device Description : Scar Fx Silicone Sheeting 1.5"x3"

Device Class :

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Scar Fx - 00642790115054 Catalog Number : 11505

Device Description : Scar Fx Silicone Sheeting 1.5"x5"

Device Class :

Duns Number: 014302733

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

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