Duns Number:371618773
Device Description: MDNC-2221 NC MKIII
Catalog Number
K9301649C
Brand Name
Nio Color 2MP LED
Version/Model Number
MDNC-2221
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
K133663
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
d01ea8ce-a49e-455c-aacb-8b19f58a03b7
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 14, 2021
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 | 105 |
2 | A medical device with a moderate to high risk that requires special controls. | 259 |