Duns Number:793169512
Device Description: 18X24CM DVIEW CR MAMMO SCR EHR-M
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
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
MUE
Product Code Name
Full field digital,system,x-ray,mammographic
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
Package DI Number
60889978188345
Quantity per Package
10
Contains DI Package
40889978188341
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
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 |