Duns Number:083171244
Device Description: Integra® DuraFlexTM Suturable Dural Graft is a natural, resorbable, collagenous device for Integra® DuraFlexTM Suturable Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.
Catalog Number
BP10608
Brand Name
Integra® DuraFlex™ Suturable Dural Graft
Version/Model Number
BP10608
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
K132850,K132850
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
18d5278d-a4a9-486d-8c21-e45b23564885
Public Version Date
September 22, 2020
Public Version Number
2
DI Record Publish Date
February 22, 2019
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |