Duns Number:021677872
Device Description: Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two st
Catalog Number
Intuition
Brand Name
Intuition
Version/Model Number
Intuition04
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K121916
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
13cba2d7-c4f6-4280-99eb-ae1b72c88b0c
Public Version Date
September 15, 2021
Public Version Number
1
DI Record Publish Date
September 07, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |