Cotton-Leung Sof-Flex CLSO-SF-7-7

GUDID 10827002496597

Cotton-Leung Sof-Flex Biliary Stent

COOK IRELAND LTD

Polymeric biliary stent, non-bioabsorbable

• Primary Device ID: 10827002496597
• NIH Device Record Key: 1d4b377b-64c9-45a3-84eb-33beba5d04f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cotton-Leung Sof-Flex
• Version Model Number: G49659
• Catalog Number: CLSO-SF-7-7
• Company DUNS: 988559035
• Company Name: COOK IRELAND LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location

Device Identifiers

Device Issuing Agency	Device ID
GS1	10827002496597 [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: 4
• Public Version Date: 2025-12-22
• Device Publish Date: 2015-11-03

On-Brand Devices [Cotton-Leung Sof-Flex]

• 10827002496603: Cotton-Leung Sof-Flex Biliary Stent
• 10827002496573: Cotton-Leung Sof-Flex Biliary Stent
• 10827002496542: Cotton-Leung Sof-Flex Biliary Stent
• 10827002496627: Cotton-Leung Sof-Flex Biliary Stent
• 10827002496610: Cotton-Leung Sof-Flex Biliary Stent
• 10827002496597: Cotton-Leung Sof-Flex Biliary Stent
• 10827002496580: Cotton-Leung Sof-Flex Biliary Stent
• 10827002496566: Cotton-Leung Sof-Flex Biliary Stent
• 10827002496559: Cotton-Leung Sof-Flex Biliary Stent