cryoICE Cryoablation System A000708

GUDID 00818354012705

ACM Footswitch

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

• Primary Device ID: 00818354012705
• NIH Device Record Key: 9dac3a3d-9761-486a-a0c8-f8d4b3f515e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cryoICE Cryoablation System
• Version Model Number: ACM1
• Catalog Number: A000708
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354012705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142203

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-08
• Device Publish Date: 2019-12-31

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