ROCHESTER ELECTRO-MEDICAL, INC.

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Device Description : DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 19 MM NEEDLE, 2.5 M TWIS DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 19 MM NEEDLE, 2.5 M TWISTED LEADWIRE, COLOR GROUP 3

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Device Description : REUSABLE ULTRALAST CUP ELECTRODES: 6 MM STAMPED GOLD DISC, 6 FT. (1.8 M), SINGLE REUSABLE ULTRALAST CUP ELECTRODES: 6 MM STAMPED 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

Device Description : DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M (60" DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M (60") TWISTED LEADWIRE, COLOR GROUP 1

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Device Description : DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.2 M (48" DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.2 M (48") TWISTED LEADWIRE, COLOR GROUP 1

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Device Description : DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M RIBB DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M RIBBON LEADWIRE (7-LEAD), COLOR GROUP SP2

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M TWISTED LEAD DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M TWISTED LEADWIRE, COLOR GROUP 1

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M TWISTED LEAD DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M TWISTED LEADWIRE, COLOR GROUP 2

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEAD DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEADWIRE, COLOR GROUP 1

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEAD DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEADWIRE, COLOR GROUP 2

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Device Description : TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 29 GA., 37 MM NEEDLE, 2.5 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 29 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE RED LEADWIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1