FDA.reportPublic FDA data

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

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
00827002007475CookG00747T9.0-65-45-M-NS-TJC2016-09-24
00827002071261CookG07126T9.0-65-45-NM-NS-TJC2016-09-24
00827002342538AprimaG34253NSSW-4.0-18-NPAS-100-HC-SST2020-10-15
00827002067622CookG06762PLVW-5.5-25-PICS2020-10-02
00827002116306ChaitG11630CTU10.0-18-CAA2020-10-02
00827002577862Check-Flo PerformerG57786RCF-4.0-21-7-J-012020-07-07
00827002577879Check-Flo PerformerG57787RCF-4.0-35-J-012020-07-07
00827002577886Check-Flo PerformerG57788RCF-5.0-35-J-012020-07-07
00827002577893Check-Flo PerformerG57789RCF-5.0-38-J-012020-07-07
00827002577909Check-Flo PerformerG57790RCF-6.0-35-J-012020-07-07
00827002577916Check-Flo PerformerG57791RCF-6.0-38-J-012020-07-07
00827002577923Check-Flo PerformerG57792RCF-7.0-35-J-012020-07-07
00827002577930Check-Flo PerformerG57793RCF-7.0-38-J-012020-07-07
00827002577947Check-Flo PerformerG57794RCF-8.0-38-J-012020-07-07
00827002577954Check-Flo PerformerG57795RCFP-5.5-25-J-012020-07-07
00827002577961Check-Flo PerformerG57796RCFW-5.0-35-012020-07-07
00827002275010TurcotteG27501HDC-500-TURCOTTE-0429922016-09-24
00827002275027TurcotteG27502HDC-600-TURCOTTE-0429922016-09-24
00827002313941VertefixG31394VBC-1002016-04-28
00827002363922ChaitG36392TDCS-100-M2016-09-24

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