Duns Number:809784593
Device Description: Post Op Kit: Natura Stomahesive Moldable Skin Barrier, Accordion Flange, Drainable, with I Post Op Kit: Natura Stomahesive Moldable Skin Barrier, Accordion Flange, Drainable, with Invisiclose Tail Closure, 33 - 45 mm, 70 mm
Catalog Number
-
Brand Name
SUR-FIT NATURA
Version/Model Number
421044
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FON
Product Code Name
Bag, Drainage, With Adhesive, Ostomy
Public Device Record Key
d01dbd9f-14e7-486f-a159-9b4e911f7441
Public Version Date
October 27, 2022
Public Version Number
4
DI Record Publish Date
November 09, 2018
Package DI Number
10768455133243
Quantity per Package
6
Contains DI Package
00768455133246
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 |