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

EverLast™ - 10816843021013 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM STAMPED TIN DISC, 8 FT. (2.5 M), RIBBON, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

NoiseFree™ - 10816843021037 Catalog Number :

Device Description : REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 6 FT. (1.8 M), RIBBON, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

NoiseFree™ - 10816843021051 Catalog Number :

Device Description : REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 6 FT. (1.8 M) REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 6 FT. (1.8 M), SINGLE, SILICONE WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 5

NoiseFree™ - 10816843021075 Catalog Number :

Device Description : REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 8 FT. (2.5 M) REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 8 FT. (2.5 M), SINGLE, SILICONE WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 5

NoiseFree™ - 10816843021099 Catalog Number :

Device Description : REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 6 FT. (1.8 M), SINGLE, S REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 6 FT. (1.8 M), SINGLE, SILICONE WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 5

NoiseFree™ - 10816843021112 Catalog Number :

Device Description : REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 8 FT. (2.5 M), SINGLE, S REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 8 FT. (2.5 M), SINGLE, SILICONE WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 5

NoiseFree™ - 10816843021136 Catalog Number :

Device Description : REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 4 FT. (1.2 M) REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 4 FT. (1.2 M), SINGLE, SILICONE WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 5

Rochester - 10816843021150 Catalog Number :

Device Description : REUSABLE EAR CLIP ELECTRODES: 9MM SILVER DISC, 6 FT. (1.8 M), PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Rochester - 10816843021174 Catalog Number :

Device Description : REUSABLE EAR CLIP ELECTRODES: 9 MM GOLD DISC, 6 FT. (1.8 M), PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Rochester - 10816843021198 Catalog Number :

Device Description : REPLACEMENT STAMPED ELECTRODE DISCS: 6 MM STAMPED TIN DISCS

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 100

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