Duns Number:017415781
Device Description: Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Dura-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Dura-Guard is chemically sterilized using ethanol and propylene oxide. Dura-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Dura-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile
Catalog Number
DG0404SN
Brand Name
DURA-GUARD Dural Repair Patch
Version/Model Number
DG0404SN
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
-
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
86c1f71b-fb95-42ff-bb36-7d75350b158e
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
October 08, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |