Duns Number:134139174
Device Description: FOGARTY BILIARY BALLOON PROBE 6F 23CM
Catalog Number
410236FP
Brand Name
FOGARTY
Version/Model Number
410236FP
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
K193379,K193379
Product Code
GCA
Product Code Name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Public Device Record Key
61ede6a6-c61e-4065-89d8-b60f552783e2
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
August 31, 2020
Package DI Number
50690103205126
Quantity per Package
5
Contains DI Package
00690103205121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHIPPER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |