EchoTip AcuCore ECHO-BX-3-22

GUDID 00827002597464

EchoTip AcuCore EUS Biopsy Needle

COOK IRELAND LTD

Ultrasound aspiration biopsy procedure kit
Primary Device ID00827002597464
NIH Device Record Key740d1414-757f-4165-a1c8-afe3eb9c445b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEchoTip AcuCore
Version Model NumberG59746
Catalog NumberECHO-BX-3-22
Company DUNS988559035
Company NameCOOK IRELAND LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry location.

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002597464 [Primary]

FDA Product Code

ODGEndoscopic ultrasound system, gastroenterology-urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-11
Device Publish Date2023-10-03

Devices Manufactured by COOK IRELAND LTD

00827002597464 - EchoTip AcuCore2023-10-11EchoTip AcuCore EUS Biopsy Needle
00827002597464 - EchoTip AcuCore2023-10-11 EchoTip AcuCore EUS Biopsy Needle
10827002306513 - COOK2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH
10827002306520 - COOK2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH
10827002307145 - COOK2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET
10827002307152 - COOK2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET
10827002482408 - BIGopsy2023-02-20 BIGopsy Backloading Biopsy Forceps
10827002480305 - Evolution2022-11-28 EVOLUTION ESOPHAGEAL, STENT SYSTEM - PARTIALLY COVERED
10827002480312 - Evolution2022-11-28 EVOLUTION ESOPHAGEAL, STENT SYSTEM - PARTIALLY COVERED

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