Echotip ClearCore ECHO-BX-19

GUDID 00827002597426

Echotip ClearCore EUS Biopsy Needle

COOK IRELAND LTD

Ultrasound aspiration biopsy procedure kit

• Primary Device ID: 00827002597426
• NIH Device Record Key: 07e6ee60-5e58-4f69-a8e1-b9df31241e2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echotip ClearCore
• Version Model Number: G59742
• Catalog Number: ECHO-BX-19
• 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
• 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 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.
• 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	00827002597426 [Primary]

FDA Product Code

• FCG: Biopsy needle

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: 2025-01-28
• Device Publish Date: 2025-01-20

On-Brand Devices [Echotip ClearCore]

• 00827002609921: Echotip ClearCore EUS Biopsy Needle
• 00827002597426: Echotip ClearCore EUS Biopsy Needle