DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 18X24CM DVIEW CR MAMMO SCR EHR-M - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: 18X24CM DVIEW CR MAMMO SCR EHR-M

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More Product Details

Catalog Number

8188344

Brand Name

DIRECTVIEW CR Mammography Cassette with EHR-M Screen

Version/Model Number

DIRECTVIEW CR Mammography Cassette with EHR-M Screen

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

P080018,P080018

Product Code Details

Product Code

MUE

Product Code Name

Full field digital,system,x-ray,mammographic

Device Record Status

Public Device Record Key

6156a5db-380b-423e-9043-ab90daa0c18e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

60889978188345

Quantity per Package

10

Contains DI Package

40889978188341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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