cryoICE Cryoablation System A000957-6

GUDID 30840143902837

cryoICE cryoFORM 10 cm Corrugated Stainless Steel Cryoablation Probe

ATRICURE, INC.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 30840143902837
• NIH Device Record Key: ec5a24a7-0c9d-4e49-adae-2cffa95e47a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cryoICE Cryoablation System
• Version Model Number: CRYOF
• Catalog Number: A000957-6
• 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: 866-349-2342
• 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
• 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

Device Dimensions

• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354016147 [Previous]
GS1	10840143902468 [Primary]
GS1	30840143902837 [Package]; Contains: 10840143902468; Package: box [1 Units]; In Commercial Distribution
GS1	50840143902701 [Package]; Package: case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180137

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

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: 2021-01-18
• Device Publish Date: 2021-01-08

On-Brand Devices [cryoICE Cryoablation System]

• 00818354016277: cryoICE Cryoablation System Cryo Module
• 00818354016147: cryoICE cryoFORM 10 cm Corrugated Stainless Steel Cryoablation Probe
• 00818354016130: cryoICE CRYO3 10 cm Smooth Aluminum Cryoablation Probe
• 00818354016123: cryoICE CRYO2 10 cm Smooth Aluminum Cryoablation Probe
• 00818354015782: ACM Accessories
• 00818354014839: cryoICE cryoFORM 10 cm Corrugated Stainless Steel Cryoablation Probe
• 00818354014549: cryoICE CRYO3 10 cm Smooth Aluminum Cryoablation Probe
• 00818354011470: cryoICE Cryoablation System Cryo Module
• 00818354011340: cryoICE CRYO2 10 cm Smooth Aluminum Cryoablation Probe
• 00818354016796: cryoICE Cryoablation System Cryo Module
• 00818354012705: ACM Footswitch
• 10840143902925: ACM Footswitch
• 30840143902837: cryoICE cryoFORM 10 cm Corrugated Stainless Steel Cryoablation Probe
• 30840143902721: cryoICE 10cm Cryoablation Probe
• 30840143902608: cryoICE 10cm Cryoablation Probe
• 10840143900426: cryoICE Cryoablation System Cryo Module