Duns Number:809784593
Device Description: Visi-Flow® Irrigation Sleeve Tail Closure
Catalog Number
-
Brand Name
SUR-FIT
Version/Model Number
175650
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
-
Product Code
EZS
Product Code Name
APPLIANCE, COLOSTOMY, DISPOSABLE
Public Device Record Key
6452ea00-b819-41fd-ac75-bf94b59fdd87
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
10768455107077
Quantity per Package
12
Contains DI Package
00768455107070
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |