C2 CryoBalloon

GUDID 04961333255313

PENTAX OF AMERICA, INC.

Gastrointestinal/biliary dilation balloon catheter

• Primary Device ID: 04961333255313
• NIH Device Record Key: 029943c7-114a-4d24-97ab-19412cf63bc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C2 CryoBalloon
• Version Model Number: FG-1055
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333255313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240457

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: 2024-09-20
• Device Publish Date: 2024-09-12

On-Brand Devices [C2 CryoBalloon]

• 04961333255320: FG-1056
• 04961333255313: FG-1055