Codonics DirectVista Thermal Film, 1436-DVB - 1436-DVB Blue Base Film (25 sheet cassette) - CODONICS INC.

Duns Number:101533727

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

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More Product Details

Catalog Number

-

Brand Name

Codonics DirectVista Thermal Film, 1436-DVB

Version/Model Number

1436-DVB

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IWZ

Product Code Name

Film, Radiographic

Device Record Status

Public Device Record Key

6a7875b0-4621-4883-9ce3-5250c8bf8daa

Public Version Date

February 13, 2020

Public Version Number

1

DI Record Publish Date

February 05, 2020

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