Cardiac Cryosurgical System

GUDID 00818354010039

15 mm Flat Face, Curved, Cardiac Reusable Probe

ATRICURE, INC.

General cryosurgical system, cryogen gas, mechanical

Primary Device ID	00818354010039
NIH Device Record Key	6460e0e1-02bf-4299-970e-7a16df547a39
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cardiac Cryosurgical System
Version Model Number	3015
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	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx
Phone	866-349-2342
Email	xxx@xxx.xxx

Operating and Storage Conditions

Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal
Special Storage Condition, Specify	Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
Handling Environment Atmospheric Pressure	Between 4481 KiloPascal and 0 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354010039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K811390

FDA Product Code

GEH	Unit, Cryosurgical, Accessories