Cotton-Leung Sof-Flex CLSO-SF-10-5

GUDID 10827002496535

Cotton-Leung Sof-Flex Biliary Stent

COOK INCORPORATED

Polymeric biliary stent, non-bioabsorbable

• Primary Device ID: 10827002496535
• NIH Device Record Key: 9460c768-2330-48f4-a0f8-c8e0a7ef39b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cotton-Leung Sof-Flex
• Version Model Number: G49653
• Catalog Number: CLSO-SF-10-5
• 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
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10827002496535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851962

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: 2025-03-03
• Device Publish Date: 2015-11-03

Devices Manufactured by COOK INCORPORATED

• 10827002496535 - Cotton-Leung Sof-Flex: 2025-03-03Cotton-Leung Sof-Flex Biliary Stent
• 10827002496535 - Cotton-Leung Sof-Flex: 2025-03-03 Cotton-Leung Sof-Flex Biliary Stent
• 00827002352674 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 00827002352681 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 00827002352698 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 00827002352704 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 00827002352711 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 10827002346014 - Fusion: 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide
• 10827002346939 - Fusion: 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide