FDA.reportPublic FDA data

Cook

Primary DI
00827002161696
Brand
Cook
Company
COOK INCORPORATED
Model
G16169
Catalog number
020707-RM6
Device description
Urodynamics Catheter
Published
2016-09-24
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
FAPCYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAPCystometric Gas (Carbon-Dioxide) On Hydraulic DeviceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002161696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002161696008270021616968270021616960827002161696

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
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
18054655025986Urethral Catheter ElectrodeSPES MEDICA SPAFAP2025-02-24
18054655026006Urethral Catheter ElectrodeSPES MEDICA SPAFAP2025-02-24
18054655030386Urethral Catheter ElectrodeSPES MEDICA SPAFAP2025-02-24
18054655025979Urethral Catheter ElectrodeSPES MEDICA SPAFAP2021-05-24
18054655026013Urethral Catheter ElectrodeSPES MEDICA SPAFAP2021-05-24
18054655012894Spes Medica Pudendal ElectrodeSPES MEDICA SPAFAP2020-03-11
08054655012897Spes Medica Pudendal ElectrodeSPES MEDICA SRLFAP2020-03-11
00827002156036CookCOOK INCORPORATEDFAP2016-09-24
00827002157392CookCOOK INCORPORATEDFAP2016-09-24
00827002158580CookCOOK INCORPORATEDFAP2016-09-24
00827002158733CookCOOK INCORPORATEDFAP2016-09-24
00827002158931MadduriCOOK INCORPORATEDFAP2016-09-24
00827002158993CookCOOK INCORPORATEDFAP2016-09-24
00827002167056CookCOOK INCORPORATEDFAP2016-09-24
00827002167803CookCOOK INCORPORATEDFAP2016-09-24
00827002168909DewanCOOK INCORPORATEDFAP2016-09-24
00827002169876CookCOOK INCORPORATEDFAP2016-09-24
00827002170438JosephCOOK INCORPORATEDFAP2016-09-24
00827002171749CookCOOK INCORPORATEDFAP2016-09-24
00827002172302CookCOOK INCORPORATEDFAP2016-09-24
00827002172524CookCOOK INCORPORATEDFAP2016-09-24
00827002172586CookCOOK INCORPORATEDFAP2016-09-24
00827002173187CookCOOK INCORPORATEDFAP2016-09-24
00827002152847SilberCOOK INCORPORATEDFAP2016-09-24
00827002154292CookCOOK INCORPORATEDFAP2016-09-24
00827002154346CookCOOK INCORPORATEDFAP2016-09-24
00827002154353CookCOOK INCORPORATEDFAP2016-09-24
00827002155404CookCOOK INCORPORATEDFAP2016-09-24
04026704072514RUSCHTELEFLEX INCORPORATEDFAP2016-09-16