Duns Number:184805166
Device Description: XenoSure Biologic Pledgets, 0.5cm x 1.0cm
Catalog Number
PL0510R25
Brand Name
XenoSure Biologic Pledgets
Version/Model Number
PL0510R25
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
ca9853f2-ce2a-476a-95f6-b9a59a57586b
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 18, 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 |