Duns Number:242512799
Device Description: The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requ The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Catalog Number
F01P1
Brand Name
COBRA-OS™
Version/Model Number
F01P1
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
K201652
Product Code
MJN
Product Code Name
Catheter, Intravascular Occluding, Temporary
Public Device Record Key
93df300d-d9b6-4683-a885-cf998209d1ab
Public Version Date
February 17, 2022
Public Version Number
1
DI Record Publish Date
February 09, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |