FIT F922LW

GUDID 10653405006411

FIT Biliary Stone Balloon Long Wire

Conmed Corporation

Biliary stone retrieval balloon catheter

• Primary Device ID: 10653405006411
• NIH Device Record Key: d04eb003-98da-416e-922d-22ab660df2b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIT
• Version Model Number: F922LW
• Catalog Number: F922LW
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10653405006411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131642

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-26
• Device Publish Date: 2017-05-12

On-Brand Devices [FIT]

• 10653405006411: FIT Biliary Stone Balloon Long Wire
• 10653405006404: FIT Biliary Stone Balloon Short Wire