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) (3) Camera, Surgical And Accessories (KQM) (2) Endoscope, Accessories, Image Post-Processing For Color Enhancement (PEA) (2) Gastroscope And Accessories, Flexible/Rigid (FDS) (2) Colonoscope And Accessories, Flexible/Rigid (FDF) (1)

Premarket Exempt

No Yes

Clear

VIDEO COLONOSCOPE - 04961333244669 Catalog Number :

Device Description : VIDEO COLONOSCOPE - PTAH

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : FDF

Prescription Use : Yes

Device Count : 1

VIDEO GASTROSCOPE - 04961333244676 Catalog Number :

Device Description : VIDEO GASTROSCOPE - PTAH

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : FDS

Prescription Use : Yes

Device Count : 1

VIDEO GASTROSCOPE - 04961333244683 Catalog Number :

Device Description : VIDEO GASTROSCOPE - PTAH

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : FDS

Prescription Use : Yes

Device Count : 1

VIDEO PROCESSOR - 04961333244690 Catalog Number :

Device Description : VIDEO PROCESSOR - PTAH (VERSA)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : PEA

Prescription Use : Yes

Device Count : 1

N/A - 04961333244706 Catalog Number :

Device Description : MS SQL STD SINGLE USER LICENSE

Device Class : 1

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

TV ONE - 04961333245161 Catalog Number :

Device Description : SCAN CONVERTER

Device Class : 1

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

N/A - 04961333245178 Catalog Number :

Device Description : DEMO CASE FOR SCOPE, PROCESSOR & MONITOR

Device Class : 1

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 1

N/A - 04961333245185 Catalog Number :

Device Description : DEMO CASE FOR POLE STAND

Device Class : 1

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 1

N/A - 04961333245192 Catalog Number :

Device Description : MIC PRE-AMP KIT (ROLLS MP-13)

Device Class : 1

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

DEFINA - 04961333245208 Catalog Number :

Device Description : DEFINA HD VIDEO PROCESSOR (US USED)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : PEA

Prescription Use : Yes

Device Count : 1

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