AtriCure cryoICE cryoSPHERE Cryoablation System A001012

GUDID 00818354016338

CRYOS-L, Packaged Assembly

ATRICURE, INC.

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• Primary Device ID: 00818354016338
• NIH Device Record Key: 5ea911c7-e863-4591-8b16-7da80f754757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriCure cryoICE cryoSPHERE Cryoablation System
• Version Model Number: CRYOS-L
• Catalog Number: A001012
• 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

Device Dimensions

• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -28 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354016338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182565

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: 2018-12-17
• Device Publish Date: 2018-11-15

On-Brand Devices [AtriCure cryoICE cryoSPHERE Cryoablation System]

• 00818354016338: CRYOS-L, Packaged Assembly
• 00818354016321: CRYOS, Packaged Assembly
• 30840143902929: CRYOS-L, Packaged Assembly
• 30840143902912: CRYOS, Packaged Assembly