FDA.reportPublic FDA data

CrossCath

Primary DI
00827002515741
Brand
CrossCath
Company
COOK INCORPORATED
Model
G51574
Catalog number
CXC3.0-1.9-14-150-P-NS-0
Device description
CrossCath Support Catheter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002515741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002515741008270025157418270025157410827002515741

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450826178Fountain®Merit Medical Systems, Inc.KRA2026-03-21
10884450470418Fountain®Merit Medical Systems, Inc.KRA2026-03-19
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-03-13
00860008103819Recana Debulking CatheterIntervene, Inc.KRA2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.KRA2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.KRA2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.KRA2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.KRA2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.KRA2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.KRA2026-03-02
10884450826352Fountain®Merit Medical Systems, Inc.KRA2026-02-21
10884450826222Fountain®Merit Medical Systems, Inc.KRA2026-02-18
10884450826543Fountain®Merit Medical Systems, Inc.KRA2026-02-14
10884450826635Fountain®Merit Medical Systems, Inc.KRA2026-02-14
G544ADM18130Agile AnglerAgile Devices, Inc.KRA2026-01-30
G544ADM18147Agile AnglerAgile Devices, Inc.KRA2026-01-30
10884450826185Fountain®Merit Medical Systems, Inc.KRA2026-01-29
10884450826208Fountain®Merit Medical Systems, Inc.KRA2026-01-16
00884450742921Merit Maestro®Merit Medical Systems, Inc.KRA2026-01-03
10884450826512Fountain®Merit Medical Systems, Inc.KRA2025-11-12
00857136004316TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.KRA2025-09-29
00857136004323TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.KRA2025-09-29
00884450742914Merit Maestro®Merit Medical Systems, Inc.KRA2025-09-19
10884450826420Fountain®Merit Medical Systems, Inc.KRA2025-08-06
10884450826482Fountain®Merit Medical Systems, Inc.KRA2025-06-03
10884450825997Fountain®Merit Medical Systems, Inc.KRA2025-05-16
10884450825546Fountain®Merit Medical Systems, Inc.KRA2025-05-13
10884450826413Fountain®Merit Medical Systems, Inc.KRA2025-05-13
00842429106228PG PROMicrovention, Inc.KRA2025-04-30
00842429118733VIA MicrocatheterMicrovention, Inc.KRA2025-04-30