MIN-R 2 Cassette with MIN-R EV 150 Screen - 24X30CM MIN-R2 CASS W/EV 150 SCR - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: 24X30CM MIN-R2 CASS W/EV 150 SCR

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More Product Details

Catalog Number

8283061

Brand Name

MIN-R 2 Cassette with MIN-R EV 150 Screen

Version/Model Number

MIN-R 2 Cassette with MIN-R EV 150 Screen

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 14, 2017

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)

-

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

EAM

Product Code Name

Screen, intensifying, radiographic

Device Record Status

Public Device Record Key

7edad288-47d5-4de9-a3bd-e8e9a9690066

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARESTREAM HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 688