AtriCure cryoICE cryoSPHERE+ Cryoablation System A001448

GUDID 10840143911736

Cryoablation Probe

ATRICURE, INC.

General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 10840143911736
• NIH Device Record Key: dc028f7b-7f1f-4941-8e50-b140029a44e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriCure cryoICE cryoSPHERE+ Cryoablation System
• Version Model Number: CRYOSP-L
• Catalog Number: A001448
• 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: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 Millimeter
• Length: 17 Inch
• Outer Diameter: 8 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	10840143911736 [Primary]
GS1	30840143911730 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	50840143911734 [Package]; Contains: 30840143911730; 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+ Cryoablation System]

• 10840143911736: Cryoablation Probe
• 10840143911729: Cryoablation Probe