ROCHESTER ELECTRO-MEDICAL, 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 Yes

Clear

Rochester - 10816843020009 Catalog Number :

Device Description : REUSABLE TIN SKIN PICK-UP DISC ELECTRODES: 9 MM TIN DISC, RED & BLACK, 2 FT. (0. REUSABLE TIN SKIN PICK-UP DISC ELECTRODES: 9 MM TIN DISC, RED & BLACK, 2 FT. (0.61 M), TWISTED WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Rochester - 10816843020023 Catalog Number :

Device Description : REUSABLE FIXED BAR ELECTRODES: 9 MM TIN DISC, 3 CM BETWEEN DISCS, 4 FT. (1.2M), REUSABLE FIXED BAR ELECTRODES: 9 MM TIN DISC, 3 CM BETWEEN DISCS, 4 FT. (1.2M), TWISTED WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Rochester - 10816843020047 Catalog Number :

Device Description : REUSABLE GROUND ELECTRODES: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 30" REUSABLE GROUND ELECTRODES: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 30" (0.76 M), HEAVY-DUTY WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Rochester - 10816843020061 Catalog Number :

Device Description : REUSABLE GROUND ELECTRODES: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 4 FT REUSABLE GROUND ELECTRODES: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 4 FT (1.2 M), HEAVY-DUTY WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Rochester - 10816843020085 Catalog Number :

Device Description : REUSABLE DIGITAL RING ELECTRODES: RED & BLACK, 2 FT. (0.61 M), HEAVY-DUTY WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

GoldSelect™ - 10816843020108 Catalog Number :

Device Description : DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 10 FT. (3.1 M), SI DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 10 FT. (3.1 M), SINGLE, PVC WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

GoldSelect™ - 10816843020122 Catalog Number :

Device Description : DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 4 FT. (1.2 M), SIN DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

GoldSelect™ - 10816843020153 Catalog Number :

Device Description : DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 4 FT. (1.2 M), SIN DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE (25/PACK)

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 25

GoldSelect™ - 10816843020177 Catalog Number :

Device Description : DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 5 FT. (1.5 M), SIN DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 5 FT. (1.5 M), SINGLE, PVC WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

GoldSelect™ - 10816843020191 Catalog Number :

Device Description : DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 5 FT. (1.5 M), SIN DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 5 FT. (1.5 M), SINGLE, PVC WIRE (25/PACK)

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 25

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