Devices

Device Recall Ultraxx

Model / Serial
Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017
Product Classification
Gastroenterology-Urology Devices
Device Class
Unclassified
Implanted device?
No
Distribution
Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
Product Description
UltraxxTM Nephrostomy Balloon Set || The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
Manufacturer
Cook Inc.
1 Event
- Recall of Device Recall Ultraxx

Manufacturer

Cook Inc.

Manufacturer Address
Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
Manufacturer Parent Company (2017)
Cook Group Incorporated
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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