C2 CryoBalloon FG-1017

GUDID 00854924006170

Controller

C2 THERAPEUTICS, INC.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00854924006170
• NIH Device Record Key: 01d251bf-21c3-48d8-9ead-48f3e593eb19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C2 CryoBalloon
• Version Model Number: FG-1017
• Catalog Number: FG-1017
• Company DUNS: 929139249
• Company Name: C2 THERAPEUTICS, 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00854924006170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160994

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-08

On-Brand Devices [C2 CryoBalloon]

• 00854924006316: 180 Standard Catheter 30-mm
• 00854924006309: 90 Standard Catheter 30-mm
• 00854924006286: Focal Standard Catheter 30-mm
• 00854924006279: 180 Pear Catheter
• 00854924006262: 90 Pear Catheter
• 00854924006248: Pear Catheter Focal
• 00854924006187: Foot Pedal
• 00854924006170: Controller