FDA.reportPublic FDA data

Cope

Primary DI
00827002481831
Brand
Cope
Company
COOK INCORPORATED
Model
G48183
Catalog number
ULT8.5-8.5-28-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
00827002481831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002481831008270024818318270024818310827002481831

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
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
06936534300030Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534300054Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306070Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306087Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306094Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306100Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306117Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306124Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306131Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306148Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306155Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306162Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306179Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306186Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306193Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306209Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306216Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306223Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306230Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306247Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306254Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306261Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306278Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306285Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306292Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306308Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306315Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306322Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306339Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306353Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20