Catalog Number

6559595

Brand Name

DRYVIEW CHROMA Imaging System

Version/Model Number

DRYVIEW CHROMA Imaging System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 08, 2018

Issuing Agency

In GS1

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

-

Product Code

LMC

Product Code Name

Camera, multi format, radiological

Public Device Record Key

9185077e-db5f-48be-8e92-23660e3f8e8c

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-