Duns Number:305524696
Device Description: Alterna Flex ostomy bag / Assura Flex ostomy bag / Alterna Ostomy pouch / Assura Ostom Alterna Flex ostomy bag / Assura Flex ostomy bag / Alterna Ostomy pouch / Assura Ostomy pouch. 1-piece closed. Opaque. Midi. Midi. Base Plate Precut Start Hole Size 40 mm, Base Plate Type Flat.
Catalog Number
12147
Brand Name
Assura
Version/Model Number
12147
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
c1b6dc62-2f46-458a-9a18-20ebea8de641
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 11, 2022
Package DI Number
00762123034019
Quantity per Package
16
Contains DI Package
00762123033784
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 |