Duns Number:021717889
Device Description: Embolic spheres
Catalog Number
-
Brand Name
LC Bead M1 70-150
Version/Model Number
VE020GS
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
a2ae97c6-90cd-4a15-805d-80b81bbb9d24
Public Version Date
January 17, 2022
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 536 |
2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
3 | A medical device with high risk that requires premarket approval | 1821 |
U | Unclassified | 35 |