Duns Number:809784593
Device Description: SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Pane SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 2 1/4"
Catalog Number
-
Brand Name
SUR-FIT NATURA
Version/Model Number
401545
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
EXH
Product Code Name
BAG, URINARY, ILEOSTOMY
Public Device Record Key
3c406c87-e828-4008-9767-b757e59f40b2
Public Version Date
October 27, 2022
Public Version Number
3
DI Record Publish Date
December 07, 2018
Package DI Number
10768455103611
Quantity per Package
24
Contains DI Package
00768455103614
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |