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) Media,Coupling,Ultrasound (MUI) (1)

Premarket Exempt

No Yes

Clear

AQUAFLEX - 10855683006460 Catalog Number : 04-25-700210

Device Description : EXABLATE UF GEL PAD 25X225mm

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 5

SCAN - 10855683006491 Catalog Number : 11-28S

Device Description : SCAN ULTRASOUND GEL SCANPAC

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 4

POLYSONIC - 10855683006514 Catalog Number : 20-50

Device Description : POLYSONIC ULTRASOUND LOTION W/ ALOE VERA 1 GAL POLYPAC

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 4

POLYSONIC - 10855683006521 Catalog Number : 21-50

Device Description : POLYSONIC ULTRASOUND LOTION 1 GAL BOTTLE POLYPAC

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 4

SIGNASPRAY - 10855683006569 Catalog Number : 18-50

Device Description : SIGNASPRAY ELECTRODE SOLUTION AND SKIN PREP 50ML BOTTLE

Device Class :

Duns Number: 002449593

Premarket Exempt : No

Product Code : GYB

Prescription Use : No

Device Count : 200

Eclipse Probe Cover - 10855683006866 Catalog Number :

Device Description : A soft disposable ultrasound probe cover

Device Class : 2

Duns Number: 002449593

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 100

Soterixmedical HD-Gel - 10855683006873 Catalog Number :

Device Description : High Definition Electrolyte Gel

Device Class : 2

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 80

Alpha-Stim - 10855683006880 Catalog Number : SL50

Device Description : Conducting solution

Device Class : 2

Duns Number: 002449593

Premarket Exempt : No

Product Code : GYB

Prescription Use : No

Device Count : 200

Alpha-Stim - 10855683006897 Catalog Number : SL250

Device Description : Conducting Solution - 250 ml

Device Class : 2

Duns Number: 002449593

Premarket Exempt : No

Product Code : GYB

Prescription Use : No

Device Count : 48

STERILE AQUASONIC - 20855683006023 Catalog Number : 01-01-4

Device Description : Sterile Aquasonic 100 Ultrasound Transmission gel, 20g packette

Device Class :

Duns Number: 002449593

Premarket Exempt : Yes

Product Code : IYO

Prescription Use : Yes

Device Count : 400

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