Duns Number:008999906
Device Description: The GANDRAS catheter is designed to be used for delivering embolic materials and radiopaqu The GANDRAS catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
Catalog Number
-
Brand Name
Gandras® catheters
Version/Model Number
5581
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 09, 2019
Issuing Agency
In HIBCC
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
-
Product Code
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
af29f830-344c-4a0f-a73b-9c1a3dacf24c
Public Version Date
October 16, 2019
Public Version Number
4
DI Record Publish Date
September 05, 2016
Package DI Number
M20655811
Quantity per Package
5
Contains DI Package
M20655810
Package Discontinue Date
October 09, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |