Duns Number:069009268
Device Description: 2 Way Foley Catheter 5cc Balloon 22fr
Catalog Number
-
Brand Name
Sunmed
Version/Model Number
7-6515-22
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
K082815,K082815
Product Code
EZL
Product Code Name
Catheter, Retention Type, Balloon
Public Device Record Key
def08b7c-89b5-41df-be93-20eade2b463a
Public Version Date
December 04, 2020
Public Version Number
9
DI Record Publish Date
October 05, 2016
Package DI Number
20889483005610
Quantity per Package
10
Contains DI Package
10889483005613
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 165 |