PARKER LABORATORIES INC

Address:286 ELDRIDGE RD.,FAIRFIELD,NJ,07004,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

Media, Electroconductive (GYB) (6) Media,Coupling,Ultrasound (MUI) (3) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1)

Premarket Exempt

No Yes

Clear

AQUASONIC CLEAR - 10855683006095 Catalog Number : 03-02

Device Description : Aquasonic Clear Ultrasound Gel, 60 gram tube

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 12

AQUASONIC CLEAR - 10855683006101 Catalog Number : 03-34

Device Description : Aquasonic Clear Ultrasound Gel, 1 Liter bottle

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 6

AQUAFLEX - 10855683006132 Catalog Number : 04-02

Device Description : Aquaflex Ultrasound Gel Pad, 2cm x 9cm gel pad

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 6

SCAN - 10855683006163 Catalog Number : 11-08

Device Description : Scan Ultrasound Gel. 8 fl. oz bottle

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 12

SPECTRA - 10855683006194 Catalog Number : 12-02

Device Description : Spectra 360 Electrode Gel, 60 gram tube

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 12

SPECTRA - 10855683006200 Catalog Number : 12-08

Device Description : Spectra 360 Electrode Gel , 250 gram tube

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 12

SIGNAGEL - 10855683006217 Catalog Number : 15-25

Device Description : Signagel Electrode Gel, 250 gram tube

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 12

SIGNAGEL - 10855683006224 Catalog Number : 15-60

Device Description : Signagel Electrode Gel, 60 gram tube

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 12

SIGNACREME - 10855683006231 Catalog Number : 17-05

Device Description : Signacreme Electrode Cream, 6 oz bottle

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : GYB

Prescription Use : No

Device Count : 12

SIGNASPRAY - 10855683006262 Catalog Number : 18-25

Device Description : Signaspray Electrode Solution and Skin Prep, 250 ml bottle

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : GYB

Prescription Use : No

Device Count : 12

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