BIOPROTECH INC.

BIOPROTECH 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) (6) Electrode, Electrocardiograph (DRX) (3) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

No

Clear

ERBE - 08809083940010 Catalog Number : 20190-162

Device Description : rocker switch; spatula electrode; L 3 m

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BIOPROTECH INC. - 08809083940980 Catalog Number :

Device Description : SG15R: 4-Disk, Cloth, Dia. 19mm, Hydrogel, EMG Surface Electrodes.

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BIOPROTECH INC. - 08809083940997 Catalog Number :

Device Description : SG15G: Ground, EMG Surface Electrode, 40x48mm, Cloth, Hydrogel

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BIOPROTECH INC. - 08809083941000 Catalog Number :

Device Description : Deep CUP EEG electrode : Disposable, EEG Cup Electrodes.

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BIOPROTECH INC. - 08809083941017 Catalog Number :

Device Description : Deep CUP EEG electrode : Disposable, EEG Cup Electrodes.

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BIOPROTECH INC. - 08809083941024 Catalog Number :

Device Description : Deep CUP EEG electrode : Disposable, EEG Cup Electrodes.

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BIOPROTECH INC. - 08809083941031 Catalog Number :

Device Description : Deep CUP EEG electrode : Disposable, EEG Cup Electrodes.

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941291 Catalog Number :

Device Description : Adult Resting ECG Electrodes, Moderate Adhesive

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941307 Catalog Number :

Device Description : Adult Resting ECG Electrodes, Moderate Adhesive

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941321 Catalog Number :

Device Description : Adult Resting ECG Electrodes, Aggressive Adhesive

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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