AtriCure cryoICE cryoSPHERE MAX Cryoablation System A001450

GUDID 10840143911750

Cryoablation Probe

ATRICURE, INC.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 10840143911750
• NIH Device Record Key: 2a4e01ae-c72c-4b56-9e47-3748e252716d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriCure cryoICE cryoSPHERE MAX Cryoablation System
• Version Model Number: CRYOSMAX-L
• Catalog Number: A001450
• Company DUNS: 006133784
• Company Name: ATRICURE, 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: false
• 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

Customer Support Contacts

• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com

Device Dimensions

• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter
• Length: 17 Inch
• Outer Diameter: 10 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143911750 [Primary]
GS1	30840143911754 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	50840143911758 [Package]; Contains: 30840143911754; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233170

FDA Product Code

• GXH: Device, Surgical, Cryogenic

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: 2024-02-23
• Device Publish Date: 2024-02-15

On-Brand Devices [AtriCure cryoICE cryoSPHERE MAX Cryoablation System]

• 10840143911750: Cryoablation Probe
• 10840143911743: Cryoablation Probe