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) (10)

Premarket Exempt

Yes

Clear

Gesiva Medical - B598GMCC0001 Catalog Number :

Device Class : 2

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMCI0001 Catalog Number :

Device Class : 2

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMCPC0001 Catalog Number :

Device Class : 2

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMLHT0001 Catalog Number :

Device Class :

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMLST0001 Catalog Number :

Device Class :

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMMHT0001 Catalog Number :

Device Class :

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMMST0001 Catalog Number :

Device Class :

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMTRK0002 Catalog Number :

Device Description : Contains one each Large Standard tension ring, Large High tension ring, Medium S Contains one each Large Standard tension ring, Large High tension ring, Medium Standard tension ring, and Medium High tension ring.

Device Class : 2

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMTRL0001 Catalog Number :

Device Class : 2

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Gesiva Medical - B598GMVPH0001 Catalog Number :

Device Class : 2

Duns Number: 068245824

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

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