PENTAX OF AMERICA, INC.

Address:3 Paragon Drive,MONTVALE,NJ,07645,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

Medical Device Data System (OUG) (2) Unit, Cryosurgical, Accessories (GEH) (1)

Premarket Exempt

No Yes

Clear

ENDOPRO NETWORK CAPTURE WORKSTATION - 04961333248018 Catalog Number :

Device Description : ENDOPRO CAPTURE WORKSTATION, NETWORK

Device Class : 1

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

ENDOPRO STANDALONEC CAPTURE WORKSTATION - 04961333248025 Catalog Number :

Device Description : ENDOPRO CAPTURE WORKSTATION, STANDALONE

Device Class : 1

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon Nitroclip - 04961333248445 Catalog Number :

Device Description : NitroClip

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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