Duns Number:793169512
Device Description: 18X24CM MIN-R2 CASS W/EV 150 SCR
Catalog Number
1117035
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
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
64326d16-1609-40c0-bf83-54276b4b5b9b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
60889971117038
Quantity per Package
6
Contains DI Package
40889971117034
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 |