FDA.reportPublic FDA data

Cook

Primary DI
00827002031005
Brand
Cook
Company
COOK INCORPORATED
Model
G03100
Catalog number
ECS-400-JHH
Device description
Endoscopic Cholangiography Set
Published
2020-10-02
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
GBZCATHETER, CHOLANGIOGRAPHY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBZCatheter, CholangiographyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002031005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002031005008270020310058270020310050827002031005

GMDN Terms#

Term, Definition table
TermDefinition
Cholangiopancreatography catheter, single-useA flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP); this is a diagnostic-therapeutic procedure that involves the x-ray of the ducts after introduction of a contrast material. It is typically a single lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization. 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
Premarket exempt
true
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
00810158211872PRINCETONPrinceton Medical Group, Inc.GBZ2024-07-30
00810158211889PRINCETONPrinceton Medical Group, Inc.GBZ2024-07-30
00733132657902GORE TIPS SetW. L. Gore & Associates, Inc.GBZ2024-07-15
14026704924353TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924360TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924377TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924384TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924421TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924438TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
G587MAS0070PRINCETONPrinceton Medical Group, Inc.GBZ2023-12-14
04049197181631Guyon Catheters RZ-Medizintechnik GmbHGBZ2023-08-16
04049197264310Metal CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197264440Metal catheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197466059FOLEY CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197466080Rotunda KatheterRZ-Medizintechnik GmbHGBZ2023-08-16
B80291000american catheter CORPAmerican Catheter Corp.GBZ2023-06-20
00827002217652COOKCOOK INCORPORATEDGBZ2022-12-08
00827002218680COOKCOOK INCORPORATEDGBZ2022-12-08
00827002220300COOKCOOK INCORPORATEDGBZ2022-12-08
00827002315907COOKCOOK INCORPORATEDGBZ2022-12-08
14026704742438TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742445TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742469TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742476TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742483TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742506TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742513TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
24026704742435TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
24026704742442TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
24026704742466TAUTTELEFLEX INCORPORATEDGBZ2022-09-23