Duns Number:101403558
Device Description: Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma t Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Catalog Number
-
Brand Name
AMPatch Stoma Cover
Version/Model Number
FR with 1 1/8" Hole
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EXE
Product Code Name
Protector, Ostomy
Public Device Record Key
59671f53-48ee-470a-95bd-8c30e345959a
Public Version Date
March 08, 2022
Public Version Number
1
DI Record Publish Date
February 28, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 134 |