Duns Number:421356265
Device Description: SIGNA Artist System Medical Device Assembly-MDR
Catalog Number
-
Brand Name
NA
Version/Model Number
SIGNA Artist
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
K163331,K202238
Product Code
LNH
Product Code Name
System, nuclear magnetic resonance imaging
Public Device Record Key
7c06694c-1dee-4a2a-83f4-ac99999bd572
Public Version Date
October 07, 2022
Public Version Number
2
DI Record Publish Date
January 12, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |