C2 CryoBalloon Ablation System

GUDID 00854924006293

Gen 2 360 Degree Standard Catheter

PENTAX OF AMERICA, INC.

Gastrointestinal/biliary dilation balloon catheter, non-medicated

• Primary Device ID: 00854924006293
• NIH Device Record Key: 83e32b69-526b-4596-986b-94947343582d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C2 CryoBalloon Ablation System
• Version Model Number: FG-1029
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, 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	00854924006293 [Primary]

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

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: 2025-04-14
• Device Publish Date: 2025-04-04

On-Brand Devices [C2 CryoBalloon Ablation System]

• 00854924006293: Gen 2 360 Degree Standard Catheter
• 00854924006255: Gen 2 360 Degree Pear Catheter