Duns Number:080816678
Device Description: ZOOM 045 144 cm RC
Catalog Number
ICRC045144
Brand Name
ZOOM™ Reperfusion Catheter
Version/Model Number
ICRC045144
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 06, 2021
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"
Yes
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
K183043,K202182
Product Code
NRY
Product Code Name
Catheter, Thrombus Retriever
Public Device Record Key
da4986c0-071d-4c7a-af2c-a4d7e48f3abb
Public Version Date
August 05, 2022
Public Version Number
5
DI Record Publish Date
March 06, 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. | 37 |