Tunner 073300

GUDID 00827002152625

Tunner Pediatric Urethral Dilator Set

COOK INCORPORATED

Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use

• Primary Device ID: 00827002152625
• NIH Device Record Key: 5e24523a-4ffc-4a0c-bb27-4ee6c8a7aa4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tunner
• Version Model Number: G15262
• Catalog Number: 073300
• 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
• 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	00827002152625 [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

• 00827002216532 - COOK: 2024-05-23 Savary Gilliard Dilator Washer
• 00827002560819 - COOK: 2024-05-23 Captura Serrated Jumbo Forcep - No Spike
• 00827002560833 - COOK: 2024-05-23 Captura Serrated Jumbo Forcep - No Spike
• 00827002214521 - COOK: 2024-04-03 GLO-TIP ERCP CATHETER
• 00827002215009 - COOK: 2024-04-03 GLO-TIP ERCP CATHETER
• 00827002217652 - COOK: 2024-04-03 CLASSIC ERCP CATHETER
• 00827002218680 - COOK: 2024-04-03 HUIBREGTSE-KATON ERCP CATHETER
• 00827002219656 - COOK: 2024-04-03 GLO-TIP ERCP CATHETER