Flexor Vue

Basic Information

• Brand Name: Flexor Vue
• Primary DI: 00827002343061
• Version / Model: G34306
• Catalog Number: FV-090045-150
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-02-05
• Public Version Status: Update
• Public Device Record Key: 32b719cc-bfe7-4c9e-9ba4-e4411dd6067c
• Distribution End Date: 2019-02-04

Device Description

Flexor, Vue Deflecting Endoscopic System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57821	Flexible ureteral sheath/fibreoptic telescope	A sterile device assembly intended to function as a flexible endoscope for the visual examination and treatment of body cavities/organs that can be accessed via the ureter for cystoscopic, nephroscopic, laparoscopic, and ureteroscopic procedures. It is introduced via the urethra and typically consists of a flexible dual-lumen sheath with a fibreoptic bundle (the telescope) that transmits images to the operator via an eyepiece or video monitor via connected adaptor and endoscopic camera. The sheath has a deflector control at the proximal end allowing steering and provides instrument access with a second working channel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002343061	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.