Duns Number:040631370
Device Description: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
Catalog Number
-
Brand Name
Cerafix® Dura Substitute
Version/Model Number
C1-5X7
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
-
Product Code
GXQ
Product Code Name
Dura Substitute
Public Device Record Key
80d35a0b-73f9-4918-8ed4-7fda54456f0d
Public Version Date
September 02, 2021
Public Version Number
3
DI Record Publish Date
March 07, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 17 |