FDA.reportPublic FDA data

Cook

Primary DI
00827002158030
Brand
Cook
Company
COOK INCORPORATED
Model
G15803
Catalog number
022209-S1
Device description
Whistle Tip Ureteral Catheter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00827002158030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002158030008270021580308270021580300827002158030

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704942057RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942060RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942077RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942088RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942095RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942101RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942114RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942125RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942138RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942149RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942152RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942163RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942170RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942183RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
20192253024255DoverCardinal Health 200, LLCKOD2026-03-20
50192253024263DoverCardinal Health 200, LLCKOD2026-03-20
50192253024270DoverCardinal Health 200, LLCKOD2026-03-20
50192253024300DoverCardinal Health 200, LLCKOD2026-03-20
20885380202596DoverCardinal Health 200, LLCKOD2026-03-20
50850058254673EZ-Advancer®HR PHARMACEUTICALS INC.KOD2026-03-06
04026704937158RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937166RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
04026704937172RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937180RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
04026704937196RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937203RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
20854913006185Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-17
20854913006192Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-17
20854913006154Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-16
20854913006161Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-16