Catalog Number

8607335

Brand Name

MIN-R 2 Cassette with MIN-R 2190 Screen

Version/Model Number

MIN-R 2 Cassette with MIN-R 2190 Screen

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EAM

Product Code Name

Screen, intensifying, radiographic

Public Device Record Key

ab385d16-e5df-4c01-b005-f2025127e0ab

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

November 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-