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, Needle, Diagnostic Electromyograph (IKT) (8) Electrode, Cutaneous (GXY) (1) Electrode, Needle (GXZ) (1)

Premarket Exempt

No Yes

Clear

UltraPoint™ - 10816843024236 Catalog Number :

Device Description : TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 37 MM NEEDLE, 2.5 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE ORANGE LEADWIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

UltraPoint™ - 10816843024250 Catalog Number :

Device Description : TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 45 MM NEEDLE, 2.5 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 45 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE ORANGE LEADWIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

UltraPoint™ - 10816843024274 Catalog Number :

Device Description : TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 25 MM NEEDLE, 2.5 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 25 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE BLUE LEADWIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

UltraPoint™ - 10816843024298 Catalog Number :

Device Description : TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 37 MM NEEDLE, 2.5 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE BLUE LEADWIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

UltraPoint™ - 10816843024311 Catalog Number :

Device Description : TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 50 MM NEEDLE, 2.5 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 50 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE BLUE LEADWIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

UltraPoint™ - 10816843024335 Catalog Number :

Device Description : TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 37 MM NEEDLE, 2.5 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE GREEN LEADWIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

UltraPoint™ - 10816843024359 Catalog Number :

Device Description : TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 50 MM NEEDLE, 2.5 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 50 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE GREEN LEADWIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

UltraPoint™ - 10816843024373 Catalog Number :

Device Description : TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 75 MM NEEDLE, 2.5 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 75 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE GREEN LEADWIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

GoldSelect™ - 10816843024403 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, MVAP LABEL

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 10

Rochester - 10816843025011 Catalog Number :

Device Description : DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 19 MM NEEDLE, 1.5 M SINGLE LEADW DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 19 MM NEEDLE, 1.5 M SINGLE LEADWIRE, COLOR GROUP A

Device Class :

Duns Number: 068156330

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

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