Duns Number:012983893
Device Description: Foley Catheter Securement device for 5-8 Fr.
Catalog Number
FCS-1075
Brand Name
Clik-FIX
Version/Model Number
FCS-1075
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EYJ
Product Code Name
Holder, Ureteral Catheter
Public Device Record Key
c22748b9-a78c-4a2d-9427-f58f156ce8f2
Public Version Date
April 26, 2019
Public Version Number
1
DI Record Publish Date
April 18, 2019
Package DI Number
10850933007297
Quantity per Package
50
Contains DI Package
00850933007290
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |