Cook SIS-11.5

GUDID 00827002217492

Stent Introducer Set

COOK IRELAND LTD

Endoscopic stent-placement system

• Primary Device ID: 00827002217492
• NIH Device Record Key: 3712b715-9c7f-412b-9e5b-37aaab19010b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cook
• Version Model Number: G21749
• Catalog Number: SIS-11.5
• Company DUNS: 988559035
• Company Name: COOK IRELAND LTD
• 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 a dry location, away from temperature extremes

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002217492 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-24

On-Brand Devices [Cook]

• 00827002219038: Nasal Biliary Drainage Set
• 00827002215863: Nasal Biliary Drainage Set
• 00827002215856: Nasal Biliary Drainage Set
• 00827002215832: Nasal Biliary Drainage Set
• 00827002214842: Nasal Biliary Drainage Set
• 00827002214712: Nasal Pancreatic Drainage Set
• 00827002214668: Nasal Pancreatic Drainage Set
• 00827002221819: 14Fr Colon Decompression Set
• 00827002250925: Pushing Catheter
• 00827002247871: Pushing Catheter
• 00827002227163: Pushing Catheter
• 00827002227156: Pushing Catheter
• 00827002226845: Stent Introducer Set
• 00827002221581: Nasal Biliary Drainage Catheter
• 00827002220911: Pushing Catheter
• 00827002220058: Guiding Catheter
• 00827002220041: Guiding Catheter
• 00827002217768: Pushing Catheter
• 00827002217744: Pushing Catheter
• 00827002217720: Pushing Catheter
• 00827002217713: Pushing Catheter
• 00827002217492: Stent Introducer Set
• 00827002216235: Pushing Catheter
• 00827002215320: Stent Introducer Set
• 00827002214439: Pushing Catheter
• 00827002214217: Nasal Biliary Drainage Catheter
• 00827002213685: Nasal Biliary Drainage Catheter
• 10827002307152: DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET
• 10827002307145: DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET
• 10827002306520: DISPOSABLE ENDOSCOPIC CLEANING BRUSH
• 10827002306513: DISPOSABLE ENDOSCOPIC CLEANING BRUSH