Duns Number:187129135
Device Description: Indicated for use during open and laparoscopic cholecystectomy procedures to inject radiop Indicated for use during open and laparoscopic cholecystectomy procedures to inject radiopaque media through the cystic duct into the biliary tree.
Catalog Number
-
Brand Name
AeroStat®
Version/Model Number
C1002
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"
Yes
For Single-Use
Yes
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
-
Product Code
FGE
Product Code Name
Catheter, Biliary, Diagnostic
Public Device Record Key
97b97324-9e73-496c-b1fa-8593433a3d21
Public Version Date
November 12, 2018
Public Version Number
3
DI Record Publish Date
August 21, 2015
Package DI Number
10607915116689
Quantity per Package
5
Contains DI Package
00607915116682
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |