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

Premarket Exempt

No Yes

Clear

Med-Dyne - 00817497020554 Catalog Number :

Device Description : PRE-WIRED HYDRO GEL ELECTRODE 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

Med-Dyne - 00817497020561 Catalog Number :

Device Description : PRE-WIRED ELECTRODE 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

Med-Dyne - 00817497020578 Catalog Number :

Device Description : PRE-WIRED HYDRO GEL ELECTRODE 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

Med-Dyne - 00817497020585 Catalog Number :

Device Description : PRE-WIRED, 48" LONG LEAD WIRE, CLOTH HYDRO GEL ELECTRODE - SET OF 3

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020592 Catalog Number :

Device Description : PRE-WIRED HYDRO GEL ELECTRODE - 48" LONG LEAD WIRE - SET OF 3

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020608 Catalog Number :

Device Description : LARGE PRE-WIRED HYDRO GEL ELECTRODE 36" LONG LEAD WIRE - SET OF 5

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020615 Catalog Number :

Device Description : SMALL PRE-WIRED ELECTRODE - 36" LONG LEAD WIRE - SET OF 5

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020622 Catalog Number :

Device Description : PRE-WIRED HYDRO GEL ELECTRODE 60" LONG LEAD WIRE - SET OF 3

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497020639 Catalog Number :

Device Description : 120" BLACK GOLD CUP ELECTRODE LEAD WIRES

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

MED-DYNE - 00817497020646 Catalog Number :

Device Description : 18" BLACK GOLD CUP ELECTRODE LEAD WIRES

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

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