FDA.reportPublic FDA data

Flexi-Tip

Primary DI
00827002140172
Brand
Flexi-Tip
Company
COOK INCORPORATED
Model
G14017
Catalog number
021106
Device description
Flexi-Tip Ureteral Catheter (Right)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002140179PackageGS110In Commercial Distribution
00827002140172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700214017910827002140179
00827002140172008270021401728270021401720827002140172

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral catheterA flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

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
14026704925732RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925749RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925763RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925770RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925787RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925947RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253029079DoverCardinal Health 200, LLCKOD2025-04-07
10192253029086DoverCardinal Health 200, LLCKOD2025-04-07
10192253029093DoverCardinal Health 200, LLCKOD2025-04-07
10192253029109DoverCardinal Health 200, LLCKOD2025-04-07
10192253029116DoverCardinal Health 200, LLCKOD2025-04-07
10192253029123DoverCardinal Health 200, LLCKOD2025-04-07
10192253030310DoverCardinal Health 200, LLCKOD2025-04-07
10192253030327DoverCardinal Health 200, LLCKOD2025-04-07
10192253030334DoverCardinal Health 200, LLCKOD2025-04-07
10192253030341DoverCardinal Health 200, LLCKOD2025-04-07
10192253030358DoverCardinal Health 200, LLCKOD2025-04-07
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253030648DoverCardinal Health 200, LLCKOD2025-01-15
10192253031041DoverCardinal Health 200, LLCKOD2025-01-15
10192253031423DoverCardinal Health 200, LLCKOD2025-01-15
10192253030624DoverCardinal Health 200, LLCKOD2025-01-14
10192253031409DoverCardinal Health 200, LLCKOD2025-01-14
10192253031416DoverCardinal Health 200, LLCKOD2025-01-14
10192253038897DoverCardinal Health 200, LLCKOD2025-01-14
10192253030303DoverCardinal Health 200, LLCKOD2024-07-10