FDA.reportPublic FDA data

Cook

Primary DI
00827002058736
Brand
Cook
Company
COOK INCORPORATED
Model
G05873
Catalog number
ULT14.0-38-40-P-32S-BSL
Device description
Biliary Drainage Catheter Ultrathane
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
GCACATHETER, BILIARY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002058736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002058736008270020587368270020587360827002058736

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainage catheterA flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. 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
06959664900093NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664900208NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901137NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901441NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901458NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902578NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902653NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902660NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903247NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903254NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903261NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664907528NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910689NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910696NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910726NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910733NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911006NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911013NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911082NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911099NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06970057571027Stone Extraction BalloonJiangsu Vedkang Medical Science and Technology Co.,Ltd.GCA2026-04-14
06948318963102AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
06948318963119AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
04711182608309Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
04711182608316Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608306Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608313Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
06959664910702NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910719NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910740NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09