Geenen Sof-Flex GPSOS-SF-5-3

GUDID 10827002496689

Geenen Sof-Flex Pancreatic Stent

COOK IRELAND LTD

Polymeric pancreatic stent, non-bioabsorbable

• Primary Device ID: 10827002496689
• NIH Device Record Key: 7d0da268-1daa-44f2-838b-fca6bdb8cf48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geenen Sof-Flex
• Version Model Number: G49668
• Catalog Number: GPSOS-SF-5-3
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes

Device Identifiers

Device Issuing Agency	Device ID
GS1	10827002496689 [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: 2019-11-20
• Device Publish Date: 2015-11-03

On-Brand Devices [Geenen Sof-Flex]

• 10827002496702: Geenen Sof-Flex Pancreatic Stent
• 10827002496696: Geenen Sof-Flex Pancreatic Stent
• 10827002496689: Geenen Sof-Flex Pancreatic Stent
• 10827002496641: Geenen Sof-Flex Pancreatic Stent
• 10827002496634: Geenen Sof-Flex Pancreatic Stent