Duns Number:001191048
Device Description: XenMatrix AB Surgical Graft
Catalog Number
1151015
Brand Name
XenMatrix AB Surgical Graft
Version/Model Number
1151015
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133223
Product Code
FTM
Product Code Name
Mesh, surgical
Public Device Record Key
b490b4dc-e88c-46cb-b940-40b5e80e946c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 23, 2014
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |