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) (6) Electrode, Electrocardiograph (DRX) (4)

Premarket Exempt

No Yes

Clear

Med-Dyne - 00817497023005 Catalog Number :

Device Description : SET OF 10 60" GOLD CUP LEAD WIRES ( BK, WH, GR, RD, BR x 2 OF EACH)

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497023012 Catalog Number :

Device Description : SET OF 10 48" GOLD CUP LEAD WIRES ( BK, WH, GR, RD, BR x 2 OF EACH)

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00817497023036 Catalog Number :

Device Description : SET OF 10 96" GOLD CUP LEAD WIRES ( BK, WH, GR, RD, BR x 2 OF EACH)

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00868795000205 Catalog Number : SCL8000

Device Description : Patient Cable, Plastic Connector for SmartMonitor 2

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00868795000212 Catalog Number : SCL9000

Device Description : Patient Cable, Metal Connector for SmartMonitor2

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00868795000229 Catalog Number : DEL3000

Device Description : Disposable Snap Electrode, Cloth/Hydrogel Adhesive - PACK OF 45

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00868795000236 Catalog Number : DEL3000A

Device Description : Disposable Snap Electrode, cloth/Hydrogel Adhesive - PACK OF 45

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00868795000243 Catalog Number :

Device Description : DISPOSABLE SNAP ELECTRODE, CLOTH/HYDROGEL ADHESIVE

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Med-Dyne - 00868795000250 Catalog Number :

Device Description : DISPOSABLE SNAP ELECTRODE, FOAM/HYDROGEL ADHESIVE

Device Class : 2

Duns Number: 826176703

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Med-Dyne - 10817497020667 Catalog Number :

Device Description : 60" GOLD CUP ELECTRODE - BLACK LEAD WIRE - SET OF 12

Device Class : 2

Duns Number: 826176703

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

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