Fusion Zilver FS-ZILBS-6-4

GUDID 10827002315553

Fusion Zilver Biliary Stent System

COOK INCORPORATED

Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent

• Primary Device ID: 10827002315553
• NIH Device Record Key: 2629ab2a-c4ee-45a2-8679-af0b0af2a963
• Commercial Distribution Discontinuation: 2017-09-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Fusion Zilver
• Version Model Number: G31555
• Catalog Number: FS-ZILBS-6-4
• Company DUNS: 079720472
• Company Name: COOK INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10827002315553 [Primary]

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: 3
• Public Version Date: 2022-04-08
• Device Publish Date: 2015-11-03

On-Brand Devices [Fusion Zilver]

• 10827002315638: Fusion Zilver Biliary Stent System
• 10827002315621: Fusion Zilver Biliary Stent System
• 10827002315614: Fusion Zilver Biliary Stent System
• 10827002315607: Fusion Zilver Biliary Stent System
• 10827002315591: Fusion Zilver Biliary Stent System
• 10827002315584: Fusion Zilver Biliary Stent System
• 10827002315577: Fusion Zilver Biliary Stent System
• 10827002315560: Fusion Zilver Biliary Stent System
• 10827002315553: Fusion Zilver Biliary Stent System