Duns Number:083171244
Device Description: DuraSeal Dural Sealant System 5mL 5 pack
Catalog Number
202050
Brand Name
DuraSeal Dural Sealant System
Version/Model Number
202050
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"
Yes
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
P040034,P040034
Product Code
NQR
Product Code Name
Sealant, Dural
Public Device Record Key
4c1f7157-c999-4ca1-84f4-bdf26086335c
Public Version Date
September 22, 2020
Public Version Number
5
DI Record Publish Date
December 29, 2016
Package DI Number
30381780000024
Quantity per Package
5
Contains DI Package
10381780000020
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 | 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 |