DuoRipe

GUDID 20888937027871

DuoRipe Cervical Ripening Balloon

Coopersurgical, Inc.

Cervical dilatation catheter

• Primary Device ID: 20888937027871
• NIH Device Record Key: 4eb3904e-c9dc-4759-8d22-6c8947c418f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuoRipe
• Version Model Number: J-CRB-184000
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937027877 [Primary]
GS1	20888937027871 [Package]; Contains: 00888937027877; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131206

FDA Product Code

• PFJ: Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-09
• Device Publish Date: 2025-12-01

On-Brand Devices [DuoRipe]

• 20888937027871: DuoRipe Cervical Ripening Balloon
• 20888937027864: DuoRipe Cervical Ripening Balloon with Stylet