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,Coupling,Ultrasound (MUI) (3) Lubricant, Patient (KMJ) (2)

Premarket Exempt

No Yes

Clear

AQUAGEL - 20855683006474 Catalog Number : 57-01-5

Device Description : AQUAGEL LUBRICATING GEL 20 g packette

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : KMJ

Prescription Use : No

Device Count : 500

AQUASONIC 100 - 30855683006037 Catalog Number : 01-02-1

Device Description : AQUASONIC 100, 60G TUBE

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 200

AQUASONIC 100 - 30855683006044 Catalog Number : 01-08-700189/40483A

Device Description : AQUASONIC 100 ULTRASOUND TRANSMISSION GEL 0.25L

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 12

AQUASONIC CLEAR - 30855683006099 Catalog Number : 03-02-1

Device Description : AQUASONC CLEAR 60G TUBE

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 200

AQUAGEL - 30855683006365 Catalog Number : 57-05-1

Device Description : AQUAGEL LUBRICATING GEL 5 OZ TUBE

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : KMJ

Prescription Use : No

Device Count : 100

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