Devices

FSOMNI, Fusion OmniTome

Model / Serial
Lot number W2501093
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Ireland
Product Description
FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.
Manufacturer
Cook Endoscopy
1 Event
- Recall of FSOMNI, Fusion OmniTome

Manufacturer

Cook Endoscopy

Manufacturer Address
Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
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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