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

System, Imaging, Pulsed Echo, Ultrasonic (IYO) (5) Media, Electroconductive (GYB) (4) Lubricant, Patient (KMJ) (1)

Premarket Exempt

No Yes

Clear

POLYSONIC - 10855683006286 Catalog Number : 20-08

Device Description : Polysonic Ultrasound Lotion w/Aloe Vera, 250 ml bottle

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 12

POLYSONIC - 10855683006323 Catalog Number : 21-08

Device Description : Polysonic Ultrasound Lotion, 250 ml bottle

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 12

TENSIVE - 10855683006330 Catalog Number : 22-60

Device Description : Tensive Conductive Adhesive Gel, 50 gram tube

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : GYB

Prescription Use : No

Device Count : 12

ECLIPSE - 10855683006347 Catalog Number : 38-01

Device Description : Eclipse Probe Cover-latex free, 64 mm / 44 x 241 mm

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 100

ECLIPSE - 10855683006354 Catalog Number : 38-03

Device Description : Eclipse Probe Cover, 83mm/43x241mm

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 100

AQUAGEL - 10855683006361 Catalog Number : 57-05

Device Description : Aquagel Lubricating Gel, 5 oz. tube

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : KMJ

Prescription Use : No

Device Count : 20

REDUX - 10855683006385 Catalog Number : 65-04

Device Description : Redux Electrolyte Gel, 4 oz tube

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 10

REDUX - 10855683006392 Catalog Number : 66-04

Device Description : Redux Electrolyte Crème, 4 oz. Tube

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 10

REDUX - 10855683006408 Catalog Number : 67-05

Device Description : Redux Electrolyte Paste, 5 oz.Tube

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 10

Parker Labs - 10855683006415 Catalog Number : 30-00

Device Description : Latex probe cover, 52mmx180mm

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : IYO

Prescription Use : No

Device Count : 100

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