| Primary Device ID | 05415067020482 |
| NIH Device Record Key | 34237cef-db7a-4186-b8d8-b404bac5b86b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MediGuide¿ |
| Version Model Number | Technology |
| Catalog Number | MG1000 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, 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 |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067020482 [Primary] |
| DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-05-02 |
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| 05415067050281 - EnSite™ | 2024-04-04 X EP System PFA Catheter Visualization Temporary Software License |