Duns Number:607846297
Device Description: DURAFORM Dural Graft Implant 2 Inches x 2 Inches (5.08cm x 5.08cm)
Catalog Number
801475US
Brand Name
DURAFORM
Version/Model Number
80-1475US
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
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
3c278ac5-873c-4498-8e4a-7d8db6a2215e
Public Version Date
September 01, 2022
Public Version Number
6
DI Record Publish Date
March 22, 2016
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 | 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 |