FDA.reportPublic FDA data

Madduri

Primary DI
00827002158931
Brand
Madduri
Company
COOK INCORPORATED
Model
G15893
Catalog number
020359
Device description
Madduri Ureteral Stone Pushing 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
00827002158931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002158931008270021589318270021589310827002158931

GMDN Terms#

Term, Definition table
TermDefinition
Biliary/urinary stone retrieval basket, single-useA flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an endoscopic procedure [e.g., endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. 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
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
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

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
00827002158993CookCOOK INCORPORATEDFAP2016-09-24
00827002161696CookCOOK 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