Duns Number:305524696
Device Description: Alterna Flex ostomy bag / Assura Flex ostomy bag. Base Plate Precut Start Hole Size 25 m Alterna Flex ostomy bag / Assura Flex ostomy bag. Base Plate Precut Start Hole Size 25 mm, Base Plate Type Flat.
Catalog Number
12174
Brand Name
Alterna
Version/Model Number
12174
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
d851cdaa-d0ca-4e27-941a-b21da3d722d3
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 11, 2022
Package DI Number
00762123034224
Quantity per Package
16
Contains DI Package
00762123033715
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 |