Atala-Shepard 118116-OW-AQ-DIL

GUDID 00827002176126

Atala-Shepard Coaxial Balloon Follower With AQ, Hydrophilic Long Taper Urethral Dilators

COOK INCORPORATED

Endoscopic-access dilator, single-use

• Primary Device ID: 00827002176126
• NIH Device Record Key: c41c75c5-61d3-4d79-95d1-4eb94fc08a56
• Commercial Distribution Discontinuation: 2017-08-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Atala-Shepard
• Version Model Number: G17612
• Catalog Number: 118116-OW-AQ-DIL
• 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: 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 dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002176126 [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

On-Brand Devices [Atala-Shepard]

• 00827002155909: Atala-Shepard Coaxial Balloon Follower
• 00827002176126: Atala-Shepard Coaxial Balloon Follower With AQ, Hydrophilic Long Taper Urethral Dilators
• 00827002172739: Atala-Shepard Coaxial Balloon Follower