Duns Number:793169512
Device Description: Imaging Plate #2 - 4 Pcs
Catalog Number
1067560
Brand Name
Imaging Plate
Version/Model Number
Imaging Plate
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
-
Product Code
EAM
Product Code Name
Screen, intensifying, radiographic
Public Device Record Key
b22a5081-a6e7-473b-994a-117860a3355e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
60889971067562
Quantity per Package
20
Contains DI Package
40889971067568
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 |