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Devices
Device Recall Fusion OmniTome
Model / Serial
Product Order Number: FS-OMNI; Lot Number: W2454655.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
International Distribution - Italy, Netherlands, Germany and Spain.
Product Description
Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Manufacturer
Cook Endoscopy
1 Event
Recall of Device Recall Fusion OmniTome
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Manufacturer
Cook Endoscopy
Manufacturer Address
Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
Source
USFDA
Language
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