Duns Number:184805166
Device Description: XenoSure Biologic Patch, 2.5cm x 15cm
Catalog Number
2.5P15
Brand Name
XenoSure Biologic Patch
Version/Model Number
2.5P15
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040835
Product Code
FTM
Product Code Name
Mesh, Surgical
Public Device Record Key
f2912b21-f72e-4a3b-b9de-d3d97ec99837
Public Version Date
April 21, 2021
Public Version Number
2
DI Record Publish Date
February 26, 2021
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 453 |
| 3 | A medical device with high risk that requires premarket approval | 22 |