COLUMBIA SCIENTIFIC LLC

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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

Clear

Columbia Scientific - 00850243006006 Catalog Number : 600-10

Device Description : Columbia 600 pig tail electrodes (1" diameter) - 10 sets per box with 1 set of Columbia 600 pig tail electrodes (1" diameter) - 10 sets per box with 1 set of Columbia 06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 10

Columbia Scientific - 00850243006013 Catalog Number : 600B-10

Device Description : Columbia 600B mini-snap electrodes (.86" diameter) with butterfly patch - 10 se Columbia 600B mini-snap electrodes (.86" diameter) with butterfly patch - 10 sets per box with (1) set of SNAP06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 10

Columbia Scientific - 00850243006020 Catalog Number : 600-30

Device Description : Columbia 600 pig tail electrodes (1" diameter) - 30 sets per box with 1 set of C Columbia 600 pig tail electrodes (1" diameter) - 30 sets per box with 1 set of Columbia 06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 30

Columbia Scientific - 00850243006037 Catalog Number : 600-50

Device Description : Columbia 600 pig tail electrodes (1" diameter) - 50 sets per box with (2) sets Columbia 600 pig tail electrodes (1" diameter) - 50 sets per box with (2) sets of Columbia 06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 50

Columbia Scientific - 00850243006044 Catalog Number : 600-100

Device Description : Columbia 600 pig tail electrodes (1" diameter) - 100 sets per box with (2) sets Columbia 600 pig tail electrodes (1" diameter) - 100 sets per box with (2) sets of Columbia 06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 100

Columbia Scientific - 00850243006051 Catalog Number : 600B-30

Device Description : Columbia 600B mini-snap electrodes (.86" diameter) with butterfly patch - 30 se Columbia 600B mini-snap electrodes (.86" diameter) with butterfly patch - 30 sets per box with (1) set of SNAP06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 30

Columbia Scientific - 00850243006068 Catalog Number : 600B-50

Device Description : Columbia 600B mini-snap electrodes (.86" diameter) with butterfly patch - 50 se Columbia 600B mini-snap electrodes (.86" diameter) with butterfly patch - 50 sets per box with (1) set of SNAP06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 50

Columbia Scientific - 00850243006075 Catalog Number : 600B-100

Device Description : Columbia 600B mini-snap electrodes (.86" diameter) with butterfly patch - 100 s Columbia 600B mini-snap electrodes (.86" diameter) with butterfly patch - 100 sets per box with (1) set of SNAP06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 100

Columbia Scientific - 00850243006082 Catalog Number : 600M-10

Device Description : Columbia 600M pig tail electrodes (.86" diameter) - 10 sets per box with (1) se Columbia 600M pig tail electrodes (.86" diameter) - 10 sets per box with (1) set of Columbia 06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 10

Columbia Scientific - 00850243006099 Catalog Number : 600M-30

Device Description : Columbia 600M pig tail electrodes (.86" diameter) - 30 sets per box with (1) se Columbia 600M pig tail electrodes (.86" diameter) - 30 sets per box with (1) set of Columbia 06 Lead Wires

Device Class :

Duns Number: 130667863

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 30

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