Duns Number:305524696
Device Description: Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy Pouch / Assura Ostom Alterna Protective Seal / Assura Protective Seal / Alterna Ostomy Pouch / Assura Ostomy pouch. 1-piece closed. Opaque. Midi. Midi. Base Plate Precut Start Hole Size 20 mm, Base Plate Max Cut Size 65 mm, Base Plate Type Flat.
Catalog Number
12140
Brand Name
Assura
Version/Model Number
12140
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
ea97ab92-88ad-4551-9043-a2e4ce959527
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 11, 2022
Package DI Number
00762123033944
Quantity per Package
16
Contains DI Package
00762123033647
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 |