FDA.reportPublic FDA data

Cook

Primary DI
00827002259812
Brand
Cook
Company
COOK INCORPORATED
Model
G25981
Catalog number
SANT-14-20-PLV
Device description
One-Step Suprapubic Introducer
Published
2020-05-12
Public version status
Update
Distribution status
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
KOBCATHETER, SUPRAPUBIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOBCatheter, Suprapubic (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182709000One-Step Suprapubic IntroducerCook Incorporated2018-12-26KOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002259812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002259812008270022598128270022598120827002259812

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic catheter introducer, reusableA rigid surgical instrument(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve, and is typically made of high-grade stainless steel. This is a reusable 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
00842071153045AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-04-28
00842071153069AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-04-28
00842071150952AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071150976AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152758MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152765MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152772MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152789MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152796MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152802MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152819MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152826MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152833MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152840MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152857MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152864MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152871MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152888MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152895MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152901MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152918MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152925MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071149932MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149949MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149956MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149963MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149970MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149987MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149994MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071150006MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16