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) (5) Lubricant, Patient (KMJ) (2) Media, Electroconductive (GYB) (2) Media, Coupling, Ultrasound (MUI) (1)

Premarket Exempt

No Yes

Clear

Timm Medical - 00855683006739 Catalog Number :

Device Description : Lubricating Gel 5 gram gel

Device Class : 1

Duns Number: 002449593

Premarket Exempt : No

Product Code : KMJ

Prescription Use : No

Device Count : 1

MedVat - 00855683006838 Catalog Number :

Device Description : Ultrasonic Gel with Aloe Vera

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

BioWrap - 00855683006852 Catalog Number :

Device Description : BioWrap Conductive Cream

Device Class : 2

Duns Number: 002449593

Premarket Exempt : No

Product Code : GYB

Prescription Use : No

Device Count : 1

1% KCl GEL - 00855683006920 Catalog Number : 99-01-730090

Device Description : Bulk packed 1% KCl gel

Device Class : 2

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 1

AQUAGEL - 10855683006019 Catalog Number : 57-02-1

Device Description : AQUAGEL LUBRICATING GEL 2 OZ TUBE

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : KMJ

Prescription Use : No

Device Count : 100

AQUASONIC - 10855683006033 Catalog Number : 01-02

Device Description : Aquasonic 100 Ultrasound Transmission Gel, 60 gram tube

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 12

AQUASONIC - 10855683006040 Catalog Number : 01-08

Device Description : Aquasonic 100 Ultrasound Transmission Gel, 0.25 Liter bottle

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 12

AQUASONIC - 10855683006057 Catalog Number : 01-20

Device Description : Aquasonic 100 Ultrasound Transmission Gel, 20g Packette

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 100

AQUASONIC - 10855683006064 Catalog Number : 01-34

Device Description : Aquasonic 100 Ultrasound Transmission Gel, 1 Liter bottle

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 6

AQUASONIC CLEAR - 10855683006088 Catalog Number : 03-08

Device Description : AQUASONIC CLEAR 0.25L BOTTLE

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 12

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