Classic ERCP-1-BT-D

GUDID 00827002572850

Classic ERCP Catheter

COOK INCORPORATED

Cholangiopancreatography catheter, single-use

• Primary Device ID: 00827002572850
• NIH Device Record Key: fae19872-dfe3-416a-b08a-5d0d64ec84a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Classic
• Version Model Number: G57285
• Catalog Number: ERCP-1-BT-D
• Company DUNS: 079720472
• 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	00827002572850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171989

FDA Product Code

• ODD: Endoscopic retrograde cholangiopancreatography (ERCP) cannula

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-06
• Device Publish Date: 2019-04-26

Devices Manufactured by COOK INCORPORATED

• 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
• 00827002220300 - COOK: 2024-04-03 CLASSIC ERCP CATHETER
• 00827002220935 - COOK: 2024-04-03 GLO-TIP ERCP CATHETER
• 00827002222267 - COOK: 2024-04-03 GLO-TIP II DOUBLE LUMEN ERCP CATHETER