CODONICS INC.

Address:17991 ENGLEWOOD DR.,Cleveland,OH,44130,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

Film, Radiographic (IWZ) (9) Gas-Machine, Anesthesia (BSZ) (1)

Premarket Exempt

No Yes

Clear

Codonics DirectVista Paper/White Film, 1417-DVP - 00814905020717 Catalog Number :

Device Description : 1417-DVP White Base Film, (80 sheet cassette)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics DirectVista Paper/White Film, 1114-DVP - 00814905020724 Catalog Number :

Device Description : 1114-DVP White Base Film, (80 sheet cassette)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics ChromaVista Paper/WhiteFilm, A-CVP - 00814905020731 Catalog Number :

Device Description : A-CVP White Base Film, (50 sheet cassette)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics ChromaVista Paper/WhiteFilm, A4-CVP - 00814905020748 Catalog Number :

Device Description : A4-CVP White Base Film, (50 sheet cassette)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics Safe Label System®(SLS) 550i Point of Care Station - 144C - 00814905020823 Catalog Number :

Device Description : Integrated computer based barcode scan & print system automatically to verify dr Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-144C

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : BSZ

Prescription Use : Yes

Device Count : 1

Codonics DirectVista Thermal Film, 1417-DVB5 - 00814905020885 Catalog Number :

Device Description : 1417-DVB5 Blue Base Film (100 sheet box)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics DirectVista Thermal Film, 1114-DVB5 - 00814905020892 Catalog Number :

Device Description : 1114-DVB5 Blue Base Film (100 sheet box)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics DirectVista Thermal Film, 810-DVB5 - 00814905020908 Catalog Number :

Device Description : 810-DVB5 Blue Base Film (100 sheet box)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics DirectVista Thermal Film, 1417-DVB5 - 00814905020915 Catalog Number :

Device Description : 1417-DVB5 Blue Base Film (100 sheet cassette)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics DirectVista Thermal Film, 1114-DVB5 - 00814905020922 Catalog Number :

Device Description : 1114-DVB5 Blue Base Film (100 sheet cassette)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

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