Epic™ E2000
GUDID 05415067034502
Heart Valve Sizer Set
ST. JUDE MEDICAL, INC.
Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable| Primary Device ID | 05415067034502 |
| NIH Device Record Key | 6139bc0b-2c1d-42e2-b0c0-7c729c46c15e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epic™ |
| Version Model Number | E2000 |
| Catalog Number | E2000 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067034502 [Primary] |
FDA Product Code
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
[05415067034502]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-28 |
| Device Publish Date | 2021-12-20 |
On-Brand Devices [Epic™]
| 05414734055666 | Supra |
| 05414734055659 | Supra |
| 05414734055642 | Supra |
| 05414734055635 | Supra |
| 05414734055628 | Supra |
| 05414734055611 | Mitral |
| 05414734055604 | Mitral |
| 05414734055598 | Mitral |
| 05414734055581 | Aortic |
| 05414734055574 | Mitral |
| 05414734055567 | Aortic |
| 05414734055550 | Mitral |
| 05414734055543 | Aortic |
| 05414734055536 | Aortic |
| 05414734055529 | Aortic |
| 05415067033154 | Stented Tissue Valve |
| 05415067033147 | Stented Tissue Valve |
| 05415067033130 | Stented Tissue Valve |
| 05415067033123 | Stented Tissue Valve |
| 05415067033116 | Stented Tissue Valve |
| 05415067033109 | Stented Tissue Valve |
| 05415067033093 | Stented Tissue Valve |
| 05415067033086 | Stented Tissue Valve |
| 05415067033079 | Stented Tissue Valve |
| 05415067033062 | Stented Tissue Valve |
| 05415067033055 | Stented Tissue Valve |
| 05415067033048 | Stented Tissue Valve |
| 05415067033031 | Stented Tissue Valve |
| 05415067033024 | Stented Tissue Valve |
| 05415067033017 | Stented Tissue Valve |
| 05415067034502 | Heart Valve Sizer Set |
| 05415067045478 | Max Stented Tissue Valve |
| 05415067045461 | Max Stented Tissue Valve |
| 05415067045454 | Max Stented Tissue Valve |
| 05415067045447 | Max Stented Tissue Valve |
Trademark Results [Epic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPIC 98503407 not registered Live/Pending |
EPIC Auto, LLC 2024-04-16 |
 EPIC 98480664 not registered Live/Pending |
Sony Music Entertainment 2024-04-02 |
 EPIC 98475945 not registered Live/Pending |
Vail Trademarks, Inc. 2024-03-29 |
 EPIC 98388723 not registered Live/Pending |
EPIC Disability Advocacy 2024-02-02 |
 EPIC 98358759 not registered Live/Pending |
GEODynamics Inc. 2024-01-16 |
 EPIC 98358420 not registered Live/Pending |
akram muhammad perviz 2024-01-16 |
 EPIC 98354891 not registered Live/Pending |
Stellar Day Services, LLC 2024-01-12 |
 EPIC 98290719 not registered Live/Pending |
EPIC WEB3, INC. 2023-11-29 |
 EPIC 98163606 not registered Live/Pending |
Pona Consulting, L.3.C. 2023-09-04 |
 EPIC 98086392 not registered Live/Pending |
Liquid Core Gum Company, LLC 2023-07-14 |
 EPIC 98059107 not registered Live/Pending |
Young People In Recovery 2023-06-26 |
 EPIC 98035144 not registered Live/Pending |
New Image Labs Corporation 2023-06-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.