FDA.reportPublic FDA data

Cook

Primary DI
00827002147034
Brand
Cook
Company
COOK INCORPORATED
Model
G14703
Catalog number
000002
Device description
Uroradiometric Catheter Set
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
OTC
false
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
00827002147034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002147034008270021470348270021470340827002147034

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic measurement systemAn assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed.

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
true
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
00827002161542CookCOOK INCORPORATEDGBL2016-11-04
00827002161559CookCOOK INCORPORATEDGBL2016-11-04
00827002161566CookCOOK INCORPORATEDGBL2016-11-04
00827002161573CookCOOK INCORPORATEDGBL2016-11-04
00827002161580CookCOOK INCORPORATEDGBL2016-11-04
00827002169807CookCOOK INCORPORATEDGBL2016-11-04
00827002170056CookCOOK INCORPORATEDGBL2016-11-04
00827002147775CookCOOK INCORPORATEDGBL2016-11-04
00827002147782CookCOOK INCORPORATEDGBL2016-11-04
00827002172371Round TipCOOK INCORPORATEDGBL2016-10-06
00827002148703CookCOOK INCORPORATEDGBL2016-09-30
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
10827002140162Flexi-TipCOOK INCORPORATEDGBL2016-09-24
10827002140179Flexi-TipCOOK INCORPORATEDGBL2016-09-24
10827002140186Flexi-TipCOOK INCORPORATEDGBL2016-09-24
10827002140230Flexi-TipCOOK INCORPORATEDGBL2016-09-24
10827002140247Flexi-TipCOOK INCORPORATEDGBL2016-09-24
10827002140254Flexi-TipCOOK INCORPORATEDGBL2016-09-24
10827002140261Flexi-TipCOOK INCORPORATEDGBL2016-09-24
10827002140278Flexi-TipCOOK INCORPORATEDGBL2016-09-24