Duns Number:809784593
Device Description: SUR-FIT Natura InvisiClose Drainable Pouch, 12 in, Transparent, 1-Sided Flocking, Filter, SUR-FIT Natura InvisiClose Drainable Pouch, 12 in, Transparent, 1-Sided Flocking, Filter, 1 3/4 in
Catalog Number
-
Brand Name
SUR-FIT NATURA
Version/Model Number
411360
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
EZQ
Product Code Name
Pouch, Colostomy
Public Device Record Key
5dd39c9c-d568-4601-827d-8dc99c4f35ec
Public Version Date
May 23, 2022
Public Version Number
3
DI Record Publish Date
April 19, 2019
Package DI Number
10768455105745
Quantity per Package
40
Contains DI Package
00768455105748
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 |