Dukal LLC

Address:2 Fleetwood Ct.,Ronkonkoma,NY,11779,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

Speculum, vaginal, nonmetal (HIB) (3) Drape, surgical, exempt (PUI) (2) STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF (GZJ) (2) ELECTRODE, CUTANEOUS (GXY) (1) Stimulator, muscle, powered (IPF) (1) blood pressure cuff (DXQ) (1)

Premarket Exempt

No Yes

Clear

Dukal - 00665973006734 Catalog Number : 20-001

Device Description : DK Fen Surg Drape 18x26, ST

Device Class : 2

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Dukal - 00665973006741 Catalog Number : 20-002

Device Description : DK Surgical Drape 18x26, ST

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Dukal - 00665973015620 Catalog Number : 6650

Device Description : DK Vag Spec Sm.

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : No

Device Count : 10

Dukal - 00665973015637 Catalog Number : 6660

Device Description : DK Vag Spec Med

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : No

Device Count : 10

Dukal - 00665973015644 Catalog Number : 6670

Device Description : DK Vag Spec Lg.

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : No

Device Count : 10

Tech-Med - 00665973016771 Catalog Number : 6012

Device Description : GM3A50E Analog EMS

Device Class : 2

Duns Number: 791014871

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Tech-Med - 00665973016788 Catalog Number : 6010

Device Description : GM3A50T(0) Analog TENS

Device Class : 2

Duns Number: 791014871

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Tech-Med - 00665973016795 Catalog Number : 6010-T

Device Description : GM3A50T Analog TENS

Device Class : 2

Duns Number: 791014871

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Tech-Med - 00665973016818 Catalog Number : 6023

Device Description : FA5050 Electrode

Device Class : 2

Duns Number: 791014871

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Tech-Med - 00665973016825 Catalog Number : 2972LF-2A

Device Description : Black Nylon cuff , 2Tb ,Latex Free, Adult

Device Class : 2

Duns Number: 791014871

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

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