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) (10)

Premarket Exempt

No Yes

Clear

Codonics DirectVista Thermal Film, 1417-DVC - 00814905020618 Catalog Number :

Device Description : 1417-DVC Clear 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-DVB - 00814905020625 Catalog Number :

Device Description : 1114-DVB 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, 810-DVB - 00814905020632 Catalog Number :

Device Description : 810-DVB 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, 810-DVC - 00814905020649 Catalog Number :

Device Description : 810-DVC Clear 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, 1436-DVB - 00814905020656 Catalog Number :

Device Description : 1436-DVB Blue Base Film (25 sheet cassette)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics DirectVista Thermal Film, 1451-DVB - 00814905020663 Catalog Number :

Device Description : 1451-DVB Blue Base Film (25 sheet cassette)

Device Class : 1

Duns Number: 101533727

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Codonics DirectVista Thermal Film, 1417-DVBT - 00814905020670 Catalog Number :

Device Description : 1417-DVBT 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, 810-DVBT - 00814905020687 Catalog Number :

Device Description : 810-DVBT 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 Paper/White Film, A-DVP - 00814905020694 Catalog Number :

Device Description : A-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, A4-DVP - 00814905020700 Catalog Number :

Device Description : A4-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

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