Duns Number:690535406
Device Description: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
Catalog Number
390-01H2
Brand Name
i-ED COIL
Version/Model Number
390-01H2
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
K192068,K210638
Product Code
HCG
Product Code Name
Device, Neurovascular Embolization
Public Device Record Key
da53df20-731d-4660-aeae-addd3e2e9150
Public Version Date
March 31, 2021
Public Version Number
3
DI Record Publish Date
June 30, 2020
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. | 1041 |
| U | Unclassified | 1 |