Duns Number:083171244
Device Description: DURAGEN 1 PK, 1x1 DOMDuraGen® Dural Graft Matrix is an absorbable implant for repair of du DURAGEN 1 PK, 1x1 DOMDuraGen® Dural Graft Matrix is an absorbable implant for repair of dura matter defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfirable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Catalog Number
ID-1101
Brand Name
DuraGen®
Version/Model Number
ID1101
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
K982180
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
ccbf5bce-8676-44a4-b38f-10d57f959c18
Public Version Date
October 26, 2022
Public Version Number
6
DI Record Publish Date
September 22, 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 |