| 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 | 
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | |
| Phone | 866-349-2342 | 
| xxx@xxx.xxx | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00818354012705 [Primary] | 
| GEH | Unit, Cryosurgical, Accessories | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-01-08 | 
| Device Publish Date | 2019-12-31 | 
| 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 |