Duns Number:080326963
Device Description: x-ray film processor, Medical
Catalog Number
1001
Brand Name
Mini Med
Version/Model Number
Mini Med 90
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
IXW
Product Code Name
Processor, Radiographic-Film, Automatic
Public Device Record Key
8187a0b5-c150-49d3-9180-163aaba53713
Public Version Date
June 27, 2019
Public Version Number
1
DI Record Publish Date
June 19, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |