Duns Number:607846297
Device Description: DURAFORM Dural Graft Implant 3 Inches x 3 Inches (7.62cm x 7.62cm)
Catalog Number
801478US
Brand Name
DURAFORM
Version/Model Number
80-1478US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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
K152481,K152481
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
a37eb5ae-14f9-4c8e-96a7-0ed659838c80
Public Version Date
September 01, 2022
Public Version Number
6
DI Record Publish Date
March 22, 2016
Package DI Number
20886704079481
Quantity per Package
5
Contains DI Package
10886704079484
Package Discontinue Date
September 01, 2022
Package Status
Not in Commercial Distribution
Package Type
Package
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1054 |
| 3 | A medical device with high risk that requires premarket approval | 11 |