Duns Number:305524696
Device Description: SenSura Click . Coupling Size Diameter 40 mm, Coupling Size Diameter 1 9/16 in, Base Plate SenSura Click . Coupling Size Diameter 40 mm, Coupling Size Diameter 1 9/16 in, Base Plate Precut Start Hole Size 20 mm, Base Plate Max Cut Size 35 mm, Baseplate Precut Start Hole Size 3/4 in, Base Plate Type Flat.
Catalog Number
10016
Brand Name
SenSura Click
Version/Model Number
10016
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EXB
Product Code Name
COLLECTOR, OSTOMY
Public Device Record Key
5e138f4d-9649-47b4-8be0-2279c361867e
Public Version Date
May 16, 2022
Public Version Number
1
DI Record Publish Date
May 06, 2022
Package DI Number
05708932408561
Quantity per Package
32
Contains DI Package
05708932408554
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |