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

UltraLast™ - 10816843020412 Catalog Number :

Device Description : REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 5 FT. (1.5 M), SINGL REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 5 FT. (1.5 M), SINGLE, KEVLAR WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

UltraLast™ - 10816843020436 Catalog Number :

Device Description : REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 6 FT. (1.8 M), SINGL REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 6 FT. (1.8 M), SINGLE, KEVLAR WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

UltraLast™ - 10816843020450 Catalog Number :

Device Description : REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 10 FT. (3.1 M), SINGLE REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 10 FT. (3.1 M), SINGLE, KEVLAR WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

UltraLast™ - 10816843020474 Catalog Number :

Device Description : REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 4 FT. (1.2 M), SINGLE, REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 4 FT. (1.2 M), SINGLE, KEVLAR WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

UltraLast™ - 10816843020498 Catalog Number :

Device Description : REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 5 FT. (1.5 M), SINGLE, REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 5 FT. (1.5 M), SINGLE, KEVLAR WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

UltraLast™ - 10816843020511 Catalog Number :

Device Description : REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 6 FT. (1.8 M), SINGLE, REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 6 FT. (1.8 M), SINGLE, KEVLAR WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

UltraLast™ - 10816843020535 Catalog Number :

Device Description : REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 8 FT. (2.5 M), SINGLE, REUSABLE ULTRALAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 8 FT. (2.5 M), SINGLE, KEVLAR WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

EverLast™ - 10816843020559 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 3 FT (0.9 M), SINGLE, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

EverLast™ - 10816843020573 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 4 FT (1.2 M), SINGLE, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

EverLast™ - 10816843020597 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 5 FT (1.5 M), SINGLE, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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