Duns Number:482661753
Device Description: CEREPAK UNIFORM XL Detachable Coil Delivery System Length - 190 cm Coil Diameter - 9 mm Co CEREPAK UNIFORM XL Detachable Coil Delivery System Length - 190 cm Coil Diameter - 9 mm Coil Length - 15.3 cm
Catalog Number
FCX180915
Brand Name
CEREPAK UNIFORM
Version/Model Number
FCX180915
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
K220040
Product Code
HCG
Product Code Name
DEVICE, NEUROVASCULAR EMBOLIZATION
Public Device Record Key
4be1b3d8-b856-46d6-99b2-8b5d70c82c72
Public Version Date
September 23, 2022
Public Version Number
1
DI Record Publish Date
September 15, 2022
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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |