EchoTip ClearCore ECHO-BX-22

GUDID 00827002609921

Echotip ClearCore EUS Biopsy Needle

COOK IRELAND LTD

Ultrasound aspiration biopsy procedure kit

• Primary Device ID: 00827002609921
• NIH Device Record Key: 7be9810d-f8af-4c4c-af9b-30a527f2ea3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoTip ClearCore
• Version Model Number: G60992
• Catalog Number: ECHO-BX-22
• 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002609921 [Primary]

FDA Product Code

• ODG: Endoscopic ultrasound system, gastroenterology-urology

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: 2025-01-22
• Device Publish Date: 2025-01-14

Devices Manufactured by COOK IRELAND LTD

• 00827002609921 - EchoTip ClearCore: 2025-01-22Echotip ClearCore EUS Biopsy Needle
• 00827002609921 - EchoTip ClearCore: 2025-01-22 Echotip ClearCore EUS Biopsy Needle
• 00827002597464 - EchoTip AcuCore: 2023-10-11 EchoTip AcuCore EUS Biopsy Needle
• 10827002306513 - COOK: 2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH
• 10827002306520 - COOK: 2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH
• 10827002307145 - COOK: 2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET
• 10827002307152 - COOK: 2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET
• 10827002482408 - BIGopsy: 2023-02-20 BIGopsy Backloading Biopsy Forceps
• 10827002480305 - Evolution: 2022-11-28 EVOLUTION ESOPHAGEAL, STENT SYSTEM - PARTIALLY COVERED