FDA.reportPublic FDA data

Cotton

Primary DI
00827002220614
Brand
Cotton
Company
COOK INCORPORATED
Model
G22061
Catalog number
CGDC-8.5-7-5
Device description
Cotton Graduated Biliary Dilation Catheter
Published
2018-06-19
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
FGEStents, drains and dilators for the biliary ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171548000Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc.2017-10-13FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002220614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002220614008270022206148270022206140827002220614

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
079720472
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
06959664925645NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15