Duns Number:184805166
Device Description: XenoSure Biologic Patch, 10cm x 16cm, eIFU
Catalog Number
e10P16
Brand Name
XenoSure Biologic Patch
Version/Model Number
e10P16
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)
-
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
c1784a19-1e90-4e8e-a14b-1425308f095a
Public Version Date
April 21, 2021
Public Version Number
5
DI Record Publish Date
July 15, 2015
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 |