Duns Number:793169512
Device Description: 18x24 MIN-R 2 CASS W/ MIN-R 2190 SCREEN
Catalog Number
8604555
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
Not in Commercial Distribution
Commercial Distribution End Date
July 04, 2017
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
ff1ccbb7-7215-4909-97e8-76159c6413c9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 27, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |