RHYTHMLINK INTERNATIONAL, LLC

Address:1140 FIRST ST. SOUTH,Columbia,SC,29209,US

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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) (9)

Premarket Exempt

No Yes

Clear

Rhythmlink® - 10816312026280 Catalog Number :

Device Description : 40 electrodes, Sticky Pad™ Surface Electrodes for NCV, Ground Pad

Device Class : 2

Duns Number: 126290993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Rhythmlink® - 10816312026297 Catalog Number :

Device Description : 40 electrodes, Sticky Pad™ Surface Electrodes for NCV, Ground Pad

Device Class : 2

Duns Number: 126290993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Rhythmlink® - 10816312026334 Catalog Number :

Device Description : InvisaDeep Cup™ EEG Electrodes

Device Class : 2

Duns Number: 126290993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 35

Rhythmlink® - 10816312026341 Catalog Number :

Device Description : Disposable Deep EEG Cup Electrodes

Device Class : 2

Duns Number: 126290993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 24

Rhythmlink® - 10816312026358 Catalog Number :

Device Description : 80 electrodes, Sticky Pad™ Surface Electrodes for NCV, Single Disc Electrodes

Device Class :

Duns Number: 126290993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 4

Rhythmlink® - 10816312026365 Catalog Number :

Device Description : 60 electrodes, Sticky Pad™ Surface Electrodes for NCV, Recording and Ground Electrode Kit

Device Class :

Duns Number: 126290993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 3

Rhythmlink® - 10816312026372 Catalog Number :

Device Description : 80 electrodes, Sticky Pad™ Surface Electrodes for NCV, Single Tab Electrodes

Device Class :

Duns Number: 126290993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 2

Rhythmlink® - 10816312026419 Catalog Number :

Device Description : Disposable Deep EEG Cup Electrodes

Device Class : 2

Duns Number: 126290993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 29

Rhythmlink® - 10816312026426 Catalog Number :

Device Description : InvisaDeep Cup™ EEG Electrodes

Device Class : 2

Duns Number: 126290993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 2

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