Duns Number:083171244
Device Description: DURAGEN 5PK, 2x2 DOMDuraGen® Dural Graft Matrix is an absorbable implant for repair of dur DURAGEN 5PK, 2x2 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
ID2205
Brand Name
DuraGen® Dural Graft Matrix
Version/Model Number
ID2205
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,K982180
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
68c41f3c-3749-49bf-87e5-df64286b9458
Public Version Date
December 14, 2021
Public Version Number
5
DI Record Publish Date
September 22, 2015
Package DI Number
30381780023580
Quantity per Package
5
Contains DI Package
10381780023586
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |