FDA.reportPublic FDA data

Cook

Primary DI
00827002034150
Brand
Cook
Company
COOK INCORPORATED
Model
G03415
Catalog number
PNS-100
Device description
Percutaneous Nephrostomy Set
Published
2020-10-02
Public version status
Update
Distribution status
Not 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
00827002034150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002034150008270020341508270020341500827002034150

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheterA sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. 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
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
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
H862GPL2T0830H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPL2T1030H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPL2T1230H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPL2T1430H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPL2T1630H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862KDL2T0617H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862KDL2T0817H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862KDL2T1017H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862LBL2T1430HB0Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862LBL2T1630HB0Ulti-Flo General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862MPL21230H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862MPL21430H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862MPL2T0625H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862MPL2T0830H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862MPL2T1030H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862NCL2T0835H0Nephro-Cath Nephrostomy Drainage CatheterURESIL, LLCGBO2021-06-09
H862NCL2T0850HB0Nephro-Cath Nephrostomy Drainage CatheterURESIL, LLCGBO2021-06-09
H862NCL2T1035H0Nephro-Cath Nephrostomy Drainage CatheterURESIL, LLCGBO2021-06-09
H862NCL2T1050HB0Nephro-Cath Nephrostomy Drainage CatheterURESIL, LLCGBO2021-06-09
H862NCL2T1235H0Nephro-Cath Nephrostomy Drainage CatheterURESIL, LLCGBO2021-06-09
H862NCL2T1250HB0Nephro-Cath Nephrostomy Drainage CatheterURESIL, LLCGBO2021-06-09
H862NCL2T1435H0Nephro-Cath Nephrostomy Drainage CatheterURESIL, LLCGBO2021-06-09