Duns Number:073797367
Catalog Number
CS2050C-MRI-UK
Brand Name
Celestial Star
Version/Model Number
CS2050C-MRI-UK
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K930711
Product Code
KZF
Product Code Name
Device, medical examination, ac powered
Public Device Record Key
1a93b3c2-507b-419f-bdb2-80b41576f45f
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
January 03, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 54 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |