Duns Number:005036025
Catalog Number
60-A0012
Brand Name
Midmark Extraoral Imaging System (EOIS)
Version/Model Number
60-A0012
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
K201667
Product Code
MUH
Product Code Name
System, x-ray, extraoral source, digital
Public Device Record Key
cdf43269-35f8-4b7e-9abf-8e5a9062bca6
Public Version Date
December 15, 2020
Public Version Number
1
DI Record Publish Date
December 07, 2020
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 | 838 |
2 | A medical device with a moderate to high risk that requires special controls. | 544 |