Duns Number:081325959
Device Description: Dural Graft Implant 1”x 1” (2.54cm x 2.54cm)
Catalog Number
NT801472US
Brand Name
DURAFORM
Version/Model Number
NT801472US
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
K152481,K152481
Product Code
GXQ
Product Code Name
Dura Substitute
Public Device Record Key
62b4d2f6-8f97-43d9-9134-19134ca5b33e
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
June 28, 2019
Package DI Number
00382830056267
Quantity per Package
5
Contains DI Package
00382830048873
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |