FDA.reportPublic FDA data

Cook

Primary DI
00827002568907
Brand
Cook
Company
COOK INCORPORATED
Model
G56890
Catalog number
DUAN-6.0-19.5-25.0-6S-PIG
Device description
Drainage Catheter Needle Set
Published
2020-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBOCATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
LJECATHETER, NEPHROSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBOCatheter, Nephrostomy, General & Plastic SurgeryGeneral, Plastic Surgery1
LJECatheter, NephrostomyUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002568907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002568907008270025689078270025689070827002568907

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
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
00827002606616OpTUS Ultra PleuralG60661OPTUS-SET-5.5-15-PIGTAIL2026-10-22
00827002606623OpTUS Ultra PleuralG60662OPTUS-TRAY-5.5-15-PIGTAIL2026-10-22
00827002606630OpTUS Ultra PleuralG60663OPTUS-SET-8.5-20-PIGTAIL2026-10-22
00827002606647OpTUS Ultra PleuralG60664OPTUS-TRAY-8.5-20-PIGTAIL2026-10-22
00827002606654OpTUS Ultra PleuralG60665OPTUS-SET-10-20-PIGTAIL2026-10-22
00827002606661OpTUS Ultra PleuralG60666OPTUS-TRAY-10-20-PIGTAIL2026-10-22
00827002606678OpTUS Ultra PleuralG60667OPTUS-SET-12-30-STRAIGHT2026-10-22
00827002606685OpTUS Ultra PleuralG60668OPTUS-TRAY-12-30-STRAIGHT2026-10-22
00827002606692OpTUS Ultra PleuralG60669OPTUS-SET-12-30-PIGTAIL2026-10-22
00827002606708OpTUS Ultra PleuralG60670OPTUS-TRAY-12-30-PIGTAIL2026-10-22
00827002606715OpTUS Ultra PleuralG60671OPTUS-SET-14-30-STRAIGHT2026-10-22
00827002606722OpTUS Ultra PleuralG60672OPTUS-TRAY-14-30-STRAIGHT2026-10-22
00827002606739OpTUS Ultra PleuralG60673OPTUS-SET-14-30-PIGTAIL2026-10-22
00827002606746OpTUS Ultra PleuralG60674OPTUS-TRAY-14-30-PIGTAIL2026-10-22
00827002606753OpTUS Ultra PleuralG60675OPTUS-SET-16-30-STRAIGHT2026-10-22
00827002606760OpTUS Ultra PleuralG60676OPTUS-TRAY-16-30-STRAIGHT2026-10-22
00827002606777OpTUS Ultra PleuralG60677OPTUS-SET-16-30-PIGTAIL2026-10-22
00827002606784OpTUS Ultra PleuralG60678OPTUS-TRAY-16-30-PIGTAIL2026-10-22
00827002606791OpTUS Ultra PleuralG60679OPTUS-SET-20-30-STRAIGHT2026-10-22
00827002606807OpTUS Ultra PleuralG60680OPTUS-TRAY-20-30-STRAIGHT2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886333006151Skater Nephrostomy Drainage CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
00886333006168Skater Nephrostomy Drainage CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
00886333006175Skater Nephrostomy Drainage CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
00886333006182Skater Nephrostomy Drainage CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
00886333006199Skater Nephrostomy CatheterARGON MEDICAL DEVICES, INC.GBO2026-10-07
00817640020387Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
00817640020394Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
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00817640020417Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
00817640020424Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
00817640020431Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
00817640020448Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
00817640020455Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
00817640020165Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-28
00817640020172Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-28
00817640020189Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-28
00817640020196Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-28
00817640020516Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-28
00817640020523Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-28
00817640020530Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-28
00817640020547Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-28
00817640021339Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640021346Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020486Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2022-04-27
00817640020493Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2022-04-27
00817640020998GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-27
00817640021643GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-27
H862MPL2T1230H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862MPLT21430H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862GPJT0620H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09