Duns Number:547055364
Catalog Number
-
Brand Name
Disposable Silicone Foley Catheter Two-way 22Fr
Version/Model Number
040-FX-022240
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"
-
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
K130908,K130908,K130908
Product Code
EZL
Product Code Name
Catheter, Retention Type, Balloon
Public Device Record Key
55cd2c6d-2917-4816-bf5d-20064212470f
Public Version Date
December 04, 2020
Public Version Number
9
DI Record Publish Date
September 20, 2016
Package DI Number
26938634494866
Quantity per Package
200
Contains DI Package
16938634494869
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 167 |