Cotton CGDC-8.5-7-5

GUDID 00827002220614

Cotton Graduated Biliary Dilation Catheter

COOK INCORPORATED

Biliary drainage catheter

• Primary Device ID: 00827002220614
• NIH Device Record Key: 0b8ab12d-8033-49c9-bb6d-9ee9431cec4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cotton
• Version Model Number: G22061
• Catalog Number: CGDC-8.5-7-5
• Company DUNS: 079720472
• Company Name: COOK INCORPORATED
• 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: true
• 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(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002220614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171548

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-20
• Device Publish Date: 2018-06-19

On-Brand Devices [Cotton]

• 00827002227323: Cotton Cannulatome
• 00827002221048: Cotton Graduated Biliary Dilation Catheter
• 00827002220614: Cotton Graduated Biliary Dilation Catheter
• 00827002219694: Cotton Cannulatome
• 00827002219441: Cotton Cannulatome