DuoRipe

Primary DI
20888937027864
Brand
DuoRipe
Company
Coopersurgical, Inc.
Model
J-CRB-184000
Device description
DuoRipe Cervical Ripening Balloon with Stylet
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131206000COOK CERVICAL RIPENING BALLOONCook, Inc.2013-09-27PFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937027864PackageGS110In Commercial Distribution
00888937027860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893702786420888937027864
00888937027860008889370278608889370278600888937027860

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937027860DuoRipeCoopersurgical, Inc.PFJ2025-12-01
00888937027877DuoRipeCoopersurgical, 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
00827002198913CookCOOK INCORPORATEDPFJ2016-09-24
00827002481497CookCOOK INCORPORATEDPFJ2016-09-24
10827002198910CookCOOK INCORPORATEDPFJ2016-09-24
10827002481494CookCOOK INCORPORATEDPFJ2016-09-24