Atala-Steinbock 118014

GUDID 00827002152328

Atala-Steinbock Balloon Follower

COOK INCORPORATED

Endoscopic-access dilator, single-use

• Primary Device ID: 00827002152328
• NIH Device Record Key: f78db759-4895-4a1c-81de-479b8ce74f9d
• Commercial Distribution Discontinuation: 2017-08-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Atala-Steinbock
• Version Model Number: G15232
• Catalog Number: 118014
• Company DUNS: 042823948
• 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: true
• 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002152328 [Primary]

FDA Product Code

• KOE: DILATOR, URETHRAL

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: 2018-06-11
• Device Publish Date: 2016-09-24

Devices Manufactured by COOK INCORPORATED

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• 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
• 10827002347110 - Fusion: 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide