Duns Number:083171244
Device Description: DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dural DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dural defects. DuraGen Secure Dural Regeneration Matrix is an easy to handle, soft, pliable, non-friable, porous collagen matrix with an anti-migration layer (hydroxypropyl metlhycellulose (HPMC)) that, when used as directed, reduces the risk of product migration or displacement, e.g. during irrigation. DuraGen Secure Dural Regeneration Matrix is supplied sterile, non-pyrogenic, and in a variety of sizes for single-use.
Catalog Number
DRM-1022
Brand Name
DuraGen® Secure
Version/Model Number
DRM1022
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"
Yes
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
K120600
Product Code
GXQ
Product Code Name
Dura Substitute
Public Device Record Key
916d092a-85ba-4511-991b-57b2b285c08f
Public Version Date
October 25, 2022
Public Version Number
7
DI Record Publish Date
July 31, 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 | 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 |