Duns Number:222870839
Device Description: Embolic spheres
Catalog Number
-
Brand Name
Bead Block 900-1200
Version/Model Number
EB2S912
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
-
Product Code
HCG
Product Code Name
Device, Neurovascular Embolization
Public Device Record Key
8cb1285c-f126-4169-9ed0-7d3b6e1825b2
Public Version Date
September 29, 2021
Public Version Number
5
DI Record Publish Date
October 05, 2015
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |
3 | A medical device with high risk that requires premarket approval | 73 |