Geenen GGDC-7-5-4

GUDID 00827002216136

Geenen Graduated Dilation Catheter

COOK INCORPORATED

Biliary drainage catheter

• Primary Device ID: 00827002216136
• NIH Device Record Key: cce9cd68-52f5-421b-b611-c759d52b4581
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geenen
• Version Model Number: G21613
• Catalog Number: GGDC-7-5-4
• 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	00827002216136 [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: 2018-12-27
• Device Publish Date: 2018-11-26

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