SME, INC. USA

SME, INC. USA

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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

Electrode, Cutaneous (GXY) (6) Media,Coupling,Ultrasound (MUI) (4)

Premarket Exempt

Yes

Clear

SME - 00851004007126 Catalog Number : SMEG

Device Description : Economy Ultrasound Gel 5 Liter

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

SME - 00851004007133 Catalog Number : SMEL

Device Description : Ultrasound Lotion 1 Gallon

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

SME - 00851004007140 Catalog Number : SMEG

Device Description : Economy Ultrasound Gel 5 Liter

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

SME - 00851004007157 Catalog Number : SMEL

Device Description : Ultrasound Lotion 1 Gallon

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

SME - 10851004007000 Catalog Number : W100

Device Description : Supertrode 1.25" Round White Cloth

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

SME - 10851004007017 Catalog Number : W102

Device Description : Supertrode 2" Round White Cloth

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

SME - 10851004007024 Catalog Number : W104

Device Description : Supertrode 2" x 2" White Cloth

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

SME - 10851004007031 Catalog Number : W106

Device Description : Supertrode 2.75" Round White Cloth

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

SME - 10851004007048 Catalog Number : W110

Device Description : Supertrode 2" x 3.5" White Cloth

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

SME - 10851004007055 Catalog Number : W116

Device Description : Supertrode 2.75" x 5" White Cloth

Device Class : 2

Duns Number: 008264868

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

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