Duns Number:042405446
Device Description: WITHOUT TIP Stent System
Catalog Number
UZAS3015
Brand Name
Neuroform Atlas
Version/Model Number
M003UZAS30150
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
P180031,P180031,P180031
Product Code
QCA
Product Code Name
Intracranial coil-assist stent
Public Device Record Key
06af4e34-0c61-4655-a231-efdd852b31e9
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
June 20, 2019
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 | 2688 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5304 |
| 3 | A medical device with high risk that requires premarket approval | 86 |