FDA.reportPublic FDA data

Cope

Primary DI
00827002481763
Brand
Cope
Company
COOK INCORPORATED
Model
G48176
Catalog number
ULT8.5-8.5-24-NUCL-B-RH
Device description
Cope Nephroureterostomy Stent Ultrathane
Published
2020-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FADStent, ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171603000Cope Nephroureterostomy Stent and Amplatz Ureteral Stent SetCook Incorporated2018-04-16FAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002481763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002481763008270024817638270024817630827002481763

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
00827002476318LumaxG47631LMGRF-7.0-80-MPA2020-12-21
00827002279407White LumaxG27940LMGRF-7.0-90-MPA2016-09-24
00827002101418White LumaxG10141LMGRF-8.0C-55-MPA2016-09-24
00827002101425White LumaxG10142LMGRF-8.0C-55-RDC2016-09-24
00827002101432White LumaxG10143LMGRF-8.0C-55-MPB2016-09-24
00827002111646White LumaxG11164LMGRF-7.0C-80-MPA-PULM2016-09-24
00827002111653White LumaxG11165LMGRF-8.0C-80-MPA-PULM2016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821925001152URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925001169URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925004221URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925004238URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925004245URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925004252URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925004429URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
08714729005254Percuflex™ Combination Stent/Nephrostomy CatheterBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031680Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031697Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031703Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031796Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031802Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031819Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031826Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031833Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031840Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031857Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032090Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032106Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032113Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032120Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032137Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048381Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048398Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048404Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048411Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048428Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048459Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048466Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24