MED-DYNE, INC.

Address:2775 SOUTH FLOYD ST.,LOUISVILLE,KY,40209,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

Cable, Electrode (IKD) (8) Cable, Transducer And Electrode, Patient, (Including Connector) (DSA) (2)

Premarket Exempt

No Yes

Clear

Med-Dyne - 00817497020424 Catalog Number :

Device Description : SET OF 10 120" DISPOSABLE DISC EEG LEAD WIRES (BK, BR, GR, RD, WH x 2 OF EACH COLOR)

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020431 Catalog Number :

Device Description : SET OF 10 48" DISPOSABLE DISC EEG LEAD WIRES (BK, BR, GR, RD, WH x 2 OF EACH COLOR)

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020448 Catalog Number :

Device Description : SET OF 10 60" DISPOSABLE DISC EEG LEAD WIRES (BK, BR, GR, RD, WH x 2 OF EACH COLOR)

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020455 Catalog Number :

Device Description : SET OF 10 72" DISPOSABLE DISC EEG LEAD WIRES (BK, BR, GR, RD, WH x 2 OF EACH COLOR)

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020462 Catalog Number :

Device Description : SET OF 10 96" DISPOSABLE DISC EEG LEAD WIRES (BK, BR, GR, RD, WH x 2 OF EACH COLOR)

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020479 Catalog Number :

Device Description : 48" Disposable Disc Leadwires RED

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020486 Catalog Number :

Device Description : SBL48 X 10 ECG Snap Electrode (BLUE) BAG OF 10

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020493 Catalog Number :

Device Description : SYL48 X 10 ECG Snap Electrode (YELLOW) BAG OF 10

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020530 Catalog Number :

Device Description : PRE-WIRED HYDROGEL ELECTRODE - 24" LONG - SET OF 3

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020547 Catalog Number :

Device Description : PRE-WIRED HYDRO GEL ELECTRODE - REGULAR - 24" LONG LEAD WIRE - SET OF 3

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

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