Oasis OA-11.5

GUDID 00827002213814

Oasis, One Action Stent Introduction System

COOK IRELAND LTD

Endoscopic stent-placement system

• Primary Device ID: 00827002213814
• NIH Device Record Key: 7b7de72a-fac9-4aab-8956-6064fad7741e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oasis
• Version Model Number: G21381
• Catalog Number: OA-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
• 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 a dry location, away from temperature extremes
• 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	00827002213814 [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 [Oasis]

• 00827002268647: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268630: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268609: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268593: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268586: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268548: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268531: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268494: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268487: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268463: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268432: Oasis One Action Stent Introduction System , with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268425: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268388: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268371: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002268364: Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum Biliary Stent
• 00827002256606: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002256590: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002256583: Oasis One Action Stent Introduction System , with Pre-Loaded Cotton Leung Biliary Stent
• 00827002256576: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002256569: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253889: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253872: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253865: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253858: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253841: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253834: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253827: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253810: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253803: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253797: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253780: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253773: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253766: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253759: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002253742: Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent
• 00827002251472: Oasis, One Action Stent Introduction System
• 00827002251465: Oasis, One Action Stent Introduction System
• 00827002221505: Oasis, One Action Stent Introduction System
• 00827002217393: Oasis, One Action Stent Introduction System
• 00827002213814: Oasis, One Action Stent Introduction System