Duns Number:413819707
Catalog Number
781315
Brand Name
Ingenia
Version/Model Number
Ingenia 1.5T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K193215,K213583
Product Code
LNH
Product Code Name
System, nuclear magnetic resonance imaging
Public Device Record Key
22aa82e4-7928-48ab-922a-be978c34fd4b
Public Version Date
June 15, 2022
Public Version Number
2
DI Record Publish Date
October 01, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 349 |