Duns Number:809784593
Device Description: Post Op Kit: Natura Two-Piece Urostomy, 2 1/4 in, Transparent, Standard, with Accuseal Tap Post Op Kit: Natura Two-Piece Urostomy, 2 1/4 in, Transparent, Standard, with Accuseal Tap, with Stomahesive Cut-To-Fit Skin Barrier
Catalog Number
-
Brand Name
SUR-FIT NATURA
Version/Model Number
416945
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2022
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
8c9b3d2f-3138-4d92-bc04-55264662c887
Public Version Date
May 23, 2022
Public Version Number
3
DI Record Publish Date
March 29, 2019
Package DI Number
10768455116161
Quantity per Package
6
Contains DI Package
00768455116164
Package Discontinue Date
May 20, 2022
Package Status
Not 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 |