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 |
05415067000989 - NA | 2024-10-09 AUX Out Cable |
05415067006028 - NA | 2024-10-09 Adapter Cable |
05415067049667 - EnSite™ | 2024-09-09 X EP System Catheter Connector Cable |
05415067049889 - Advisor™ HD Grid X, Sensor Enabled™ | 2024-09-02 High Density Mapping Catheter |
05415067050182 - Agilis™ NxT Steerable Introducer Dual-Reach™ | 2024-08-23 Steerable Introducer |
05415067049704 - EnSite™ | 2024-08-22 X EP System Software Upgrade |
05415067049711 - EnSite™ | 2024-08-22 X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade |
05415067049988 - EnSite™ | 2024-08-22 X EP System OTA Certificate Software License |