Cook

Primary DI
00827002198913
Brand
Cook
Company
COOK INCORPORATED
Model
G19891
Catalog number
J-CRBS-184000
Device description
Cook, Cervical Ripening Balloon With Stylet
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
PFJCatheter, balloon, dilation of cervical canal prior to labor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To LaborObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002198910PackageGS110Not in Commercial Distribution
00827002198913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700219891010827002198910
00827002198913008270021989138270021989130827002198913

GMDN Terms#

Term, Definition table
TermDefinition
Cervical dilatation catheterA flexible, tube-like device, typically with two or more inflatable balloons at the distal working end, designed to dilate (stretch open) the cervical canal after insertion through the cervical os and expansion of the balloons to assist in obstetrical or gynaecological procedures. It may be used for labour induction, spontaneously occurring labour, non-progressive labour, cervical dystocia, undesirable prolonged uterine contractions, and intrauterine foetal death (IUFD) where delivery of the foetus is difficult. Such procedures may be performed at or prior to full-term pregnancy. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

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
00888937027860DuoRipeCoopersurgical, Inc.PFJ2025-12-01
00888937027877DuoRipeCoopersurgical, Inc.PFJ2025-12-01
20888937027864DuoRipeCoopersurgical, Inc.PFJ2025-12-01
20888937027871DuoRipeCoopersurgical, Inc.PFJ2025-12-01
H671CVX1000CVX-RIPEUTAH MEDICAL PRODUCTS, INC.PFJ2018-11-16
H671CVX1001CVX-RIPEUTAH MEDICAL PRODUCTS, INC.PFJ2018-11-16
00827002481497CookCOOK INCORPORATEDPFJ2016-09-24
10827002198910CookCOOK INCORPORATEDPFJ2016-09-24
10827002481494CookCOOK INCORPORATEDPFJ2016-09-24