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

Camera, Multi Format, Radiological (LMC) (6) Gas-Machine, Anesthesia (BSZ) (4)

Premarket Exempt

No Yes

Clear

Codonics SLS500i Operating Software - 00814905020007 Catalog Number :

Device Description : V2.1.1 Operating Software for the Codonics Safe Label System® 500i Point of Care Station

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : BSZ

Prescription Use : Yes

Device Count : 1

Codonics SLS500i Operating Software - 00814905020014 Catalog Number :

Device Description : V2.1.2 Operating Software for the Codonics Safe Label System® 500i Point of Care Station

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : BSZ

Prescription Use : Yes

Device Count : 1

Codonics SLS500i Operating Software - 00814905020021 Catalog Number :

Device Description : V2.1.3 Operating Software for the Codonics Safe Label System® 500i Point of Care Station

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : BSZ

Prescription Use : Yes

Device Count : 1

Codonics Safe Label System® Administration Tool - 00814905020038 Catalog Number :

Device Description : V2.1.0 Administration Tool compatible with Codonics Safe Label System® 500i Poin V2.1.0 Administration Tool compatible with Codonics Safe Label System® 500i Point of Care Station

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : BSZ

Prescription Use : Yes

Device Count : 1

Codonics Horizon® Operating Software - 00814905020045 Catalog Number :

Device Description : V2.1.3 Operating Software for Codonics Horizon® Imagers serial number prefix 50C V2.1.3 Operating Software for Codonics Horizon® Imagers serial number prefix 50C, 51C, and 52C

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® Operating Software - 00814905020052 Catalog Number :

Device Description : V3.0.2 Operating Software for Codonics Horizon® Imagers serial number prefix 53C V3.0.2 Operating Software for Codonics Horizon® Imagers serial number prefix 53C, 54C, and 55C

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® Operating Software - 00814905020069 Catalog Number :

Device Description : V4.1.2 Operating Software for Codonics Horizon® GS/G2/G1 Imagers serial number prefix 150C

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® Ci Multi-media Imager - 00814905020076 Catalog Number :

Device Description : Grayscale/Color Desktop Ci Format Film and Paper Diagnostic Imager

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® G1 Multi-media Imager - 00814905020083 Catalog Number :

Device Description : Grayscale Desktop Large Format Film and Paper Diagnostic Imager, 1 Media Input

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

Codonics Horizon® G2 Multi-media Imager - 00814905020090 Catalog Number :

Device Description : Grayscale Desktop Large Format Film and Paper Diagnostic Imager, 2 Media Input

Device Class : 2

Duns Number: 101533727

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

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