FDA.reportPublic FDA data

Cook

Primary DI
00827002161580
Brand
Cook
Company
COOK INCORPORATED
Model
G16158
Catalog number
021425
Device description
Open-End Tapered Tip Ureteral Catheter (Left)
Published
2016-11-04
Public version status
Update
Distribution status
Not 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
GBLCATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBLCatheter, Ureteral, General & Plastic SurgeryGastroenterology, UrologyN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002161580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002161580008270021615808270021615800827002161580

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Premarket exempt
true
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
00827002606616OpTUS Ultra PleuralG60661OPTUS-SET-5.5-15-PIGTAIL2026-10-22
00827002606623OpTUS Ultra PleuralG60662OPTUS-TRAY-5.5-15-PIGTAIL2026-10-22
00827002606630OpTUS Ultra PleuralG60663OPTUS-SET-8.5-20-PIGTAIL2026-10-22
00827002606647OpTUS Ultra PleuralG60664OPTUS-TRAY-8.5-20-PIGTAIL2026-10-22
00827002606654OpTUS Ultra PleuralG60665OPTUS-SET-10-20-PIGTAIL2026-10-22
00827002606661OpTUS Ultra PleuralG60666OPTUS-TRAY-10-20-PIGTAIL2026-10-22
00827002606678OpTUS Ultra PleuralG60667OPTUS-SET-12-30-STRAIGHT2026-10-22
00827002606685OpTUS Ultra PleuralG60668OPTUS-TRAY-12-30-STRAIGHT2026-10-22
00827002606692OpTUS Ultra PleuralG60669OPTUS-SET-12-30-PIGTAIL2026-10-22
00827002606708OpTUS Ultra PleuralG60670OPTUS-TRAY-12-30-PIGTAIL2026-10-22
00827002606715OpTUS Ultra PleuralG60671OPTUS-SET-14-30-STRAIGHT2026-10-22
00827002606722OpTUS Ultra PleuralG60672OPTUS-TRAY-14-30-STRAIGHT2026-10-22
00827002606739OpTUS Ultra PleuralG60673OPTUS-SET-14-30-PIGTAIL2026-10-22
00827002606746OpTUS Ultra PleuralG60674OPTUS-TRAY-14-30-PIGTAIL2026-10-22
00827002606753OpTUS Ultra PleuralG60675OPTUS-SET-16-30-STRAIGHT2026-10-22
00827002606760OpTUS Ultra PleuralG60676OPTUS-TRAY-16-30-STRAIGHT2026-10-22
00827002606777OpTUS Ultra PleuralG60677OPTUS-SET-16-30-PIGTAIL2026-10-22
00827002606784OpTUS Ultra PleuralG60678OPTUS-TRAY-16-30-PIGTAIL2026-10-22
00827002606791OpTUS Ultra PleuralG60679OPTUS-SET-20-30-STRAIGHT2026-10-22
00827002606807OpTUS Ultra PleuralG60680OPTUS-TRAY-20-30-STRAIGHT2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002161542CookCOOK INCORPORATEDGBL2016-11-04
00827002161559CookCOOK INCORPORATEDGBL2016-11-04
00827002161566CookCOOK INCORPORATEDGBL2016-11-04
00827002161573CookCOOK INCORPORATEDGBL2016-11-04
00827002169807CookCOOK INCORPORATEDGBL2016-11-04
00827002170056CookCOOK INCORPORATEDGBL2016-11-04
00827002147034CookCOOK INCORPORATEDGBL2016-11-04
00827002147775CookCOOK INCORPORATEDGBL2016-11-04
00827002147782CookCOOK INCORPORATEDGBL2016-11-04
00827002172371Round TipCOOK INCORPORATEDGBL2016-10-06
00827002148703CookCOOK INCORPORATEDGBL2016-09-30
00827002140271Flexi-TipCOOK INCORPORATEDGBL2016-09-24
00827002140325Whistle TipCOOK INCORPORATEDGBL2016-09-24
00827002140332Whistle TipCOOK INCORPORATEDGBL2016-09-24
00827002140400Whistle TipCOOK INCORPORATEDGBL2016-09-24
00827002140417Whistle TipCOOK INCORPORATEDGBL2016-09-24
00827002140530Round TipCOOK INCORPORATEDGBL2016-09-24
00827002148741CookCOOK INCORPORATEDGBL2016-09-24
00827002150362CookCOOK INCORPORATEDGBL2016-09-24
00827002158597Whistle TipCOOK INCORPORATEDGBL2016-09-24
00827002159402CookCOOK INCORPORATEDGBL2016-09-24
00827002167926Flexi-TipCOOK INCORPORATEDGBL2016-09-24
00827002171602CookCOOK INCORPORATEDGBL2016-09-24
00827002172623Whistle TipCOOK INCORPORATEDGBL2016-09-24
00827002178199CookCOOK INCORPORATEDGBL2016-09-24
00827002179158Flexi-TipCOOK INCORPORATEDGBL2016-09-24
00827002187900Flexi-TipCOOK INCORPORATEDGBL2016-09-24
00827002188839CookCOOK INCORPORATEDGBL2016-09-24
10827002140148Flexi-TipCOOK INCORPORATEDGBL2016-09-24
10827002140155Flexi-TipCOOK INCORPORATEDGBL2016-09-24