Duns Number:806136177
Catalog Number
EX600
Brand Name
Cordis ExoSeal Vascular Closure Device
Version/Model Number
EX600
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
-
Product Code
MGB
Product Code Name
DEVICE, HEMOSTASIS, VASCULAR
Public Device Record Key
cf564b9d-7a04-4c73-a23f-3d990257f515
Public Version Date
August 03, 2022
Public Version Number
10
DI Record Publish Date
September 19, 2014
Package DI Number
20705032058855
Quantity per Package
10
Contains DI Package
10705032058858
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2567 |
3 | A medical device with high risk that requires premarket approval | 204 |