Duns Number:083171244
Device Description: SUTURABLE DURAGEN, 1PK, 1x3 Suturable DuraGen™ Dural Regeneration Matrix is an absorbable SUTURABLE DURAGEN, 1PK, 1x3 Suturable DuraGen™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, nonpyrogenic, for single use in double peel packages in a vairety of sizes. Suturable DuraGen may be applied using either onlay or suturing technique depending on clinical need and surgeon preference.
Catalog Number
DURS-1391
Brand Name
DuraGen®
Version/Model Number
DURS1391
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
K043427
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
c2c539f4-d6bf-4cef-8089-967f313d43be
Public Version Date
October 25, 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 |