Duns Number:080816678
Device Description: ZOOM 035 158 cm RC
Catalog Number
ICRC035158
Brand Name
ZOOM™ Reperfusion Catheter
Version/Model Number
ICRC035158
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
-
Product Code
NRY
Product Code Name
Catheter, Thrombus Retriever
Public Device Record Key
efd3a614-f154-4a2d-8ba6-d7184773136d
Public Version Date
August 05, 2022
Public Version Number
5
DI Record Publish Date
July 26, 2019
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 |