PEPIN MANUFACTURING, INC.

PEPIN MANUFACTURING, 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

Electrode, Cutaneous (GXY) (10)

Premarket Exempt

No

Clear

AdvanTrode - 00677346310010 Catalog Number :

Device Description : 1" (2.5cm) Round

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

AdvanTrode - 00677346310027 Catalog Number :

Device Description : 1.375" (3.5cm) Round

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

AdvanTrode - 00677346310034 Catalog Number :

Device Description : 1.375" (3.5cm) Round with Snap

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

AdvanTrode - 00677346310041 Catalog Number :

Device Description : 2" (5cm) Round

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

AdvanTrode - 00677346310058 Catalog Number :

Device Description : 2" x 2" (5cm x 5cm) Square

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

AdvanTrode - 00677346310065 Catalog Number :

Device Description : 1.5" x 2.5" (4cm x 6.5cm) Oval

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

AdvanTrode - 00677346310072 Catalog Number :

Device Description : 2" x 4" (5cm x 10cm) Oval

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

AdvanTrode - 00677346310089 Catalog Number :

Device Description : 1.75" x 3.75" (4.5cm x 9.5cm) Rectangle

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

AdvanTrode - 00677346310096 Catalog Number :

Device Description : 3" (7.5cm) Round

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

AdvanTrode - 00677346310102 Catalog Number :

Device Description : 3" x 5" (7.5cm x 13cm) Rectangle

Device Class :

Duns Number: 807703996

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 2

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