GESIVA MEDICAL LLC

GESIVA MEDICAL LLC

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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

Device, External Penile Rigidity (LKY) (2)

Premarket Exempt

Yes

Clear

Gesiva Medical - B598GMVTS0001 Catalog Number :

Device Class : 2

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMXLC00020 Catalog Number :

Device Description : Extra Large Clear Plastic Cylinder for use with the Gesiva Medical Vacuum Therapy System.

Device Class : 2

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

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