Codonics Horizon® Multi-media Imager - Grayscale Desktop Large Format Film and Paper - CODONICS INC.

Duns Number:101533727

Device Description: Grayscale Desktop Large Format Film and Paper Diagnostic Imager - 150C

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More Product Details

Catalog Number

-

Brand Name

Codonics Horizon® Multi-media Imager

Version/Model Number

150C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K021054

Product Code Details

Product Code

LMC

Product Code Name

Camera, Multi Format, Radiological

Device Record Status

Public Device Record Key

01758778-368d-458b-8836-c99cb64857a9

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

August 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CODONICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 30