Device product
IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
Z-1550-2013
Product summary
- Event
- Event 65245
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-1550-2013
Official wording
Reason: There was an error on the outer labeling of this device. The inner label was correct.
Code information: Model Number: S-05-100-120-G3; Lot Number 01049037
Distribution pattern: Nationwide Distribution to the states of FL, NY, and PA.
Derived failure modes
-
Unknown
There was an error on the outer labeling of this device. The inner label was correct.