FDA.reportPublic FDA data

Cook

Primary DI
00827002568914
Brand
Cook
Company
COOK INCORPORATED
Model
G56891
Catalog number
DUAN-7.0-19.5-25.0-8S-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
00827002568914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002568914008270025689148270025689140827002568914

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
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817640020387Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
00817640020394Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
00817640020400Nephro-Stent Nephroureteral Stent CatheterURESIL, LLCLJE2022-04-29
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
H862GPJT0825H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPJT1025H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPJT1225H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPJT1425H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPL2T0625H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09