| Primary Device ID | 30840143904114 |
| NIH Device Record Key | 8a9dbbf7-af27-4f44-8445-7046f2a70350 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AtriCure Isolator Synergy Clamp and Guide System |
| Version Model Number | OLH |
| Catalog Number | A001143SB |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 866-449-2342 |
| SEhlert@atricure.com |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840143904110 [Previous] |
| GS1 | 10840143905193 [Primary] |
| GS1 | 30840143904114 [Package] Contains: 10840143905193 Package: box [1 Units] In Commercial Distribution |
| GS1 | 50840143903760 [Package] Package: Case [4 Units] In Commercial Distribution |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-01-12 |
| Device Publish Date | 2023-01-04 |
| 30840143904114 | Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide |
| 10840143905834 | Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide |