MOSAIC ULTRA™
GUDID 00763000318376
SIZERS 7308U MOSAIC ULTRA AORTIC 26L CE
MEDTRONIC 3F THERAPEUTICS, INC.
Heart valve annulus sizer, reusable| Primary Device ID | 00763000318376 |
| NIH Device Record Key | 93f23896-0025-4a61-b24e-b4d50de8fd9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MOSAIC ULTRA™ |
| Version Model Number | 7308U |
| Company DUNS | 079527232 |
| Company Name | MEDTRONIC 3F THERAPEUTICS, 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000318376 [Primary] |
FDA Product Code
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
[00763000318376]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-19 |
| Device Publish Date | 2024-08-11 |
Devices Manufactured by MEDTRONIC 3F THERAPEUTICS, INC.
| 00763000318376 - MOSAIC ULTRA™ | 2024-08-19SIZERS 7308U MOSAIC ULTRA AORTIC 26L CE |
| 00763000318376 - MOSAIC ULTRA™ | 2024-08-19 SIZERS 7308U MOSAIC ULTRA AORTIC 26L CE |
| 00763000318383 - MOSAIC™ | 2024-08-19 SIZERS 7308C MOSAIC AORTIC 26L CE |
| 00885074426815 - Duran AnCore® | 2024-03-18 TOOL 7620H HANDLE DURAN ANCORE 14L |
| 00643169402546 - HANCOCK II ULTRA™ SUPRA-X™ | 2023-09-26 SIZERS 7505UX HKII ULT SUPRA-X AOR 26L |
| 00763000318451 - CG Future™ | 2023-02-13 SIZER SET 7638S CG FUTURE 26L CE |
| 00763000318499 - Duran AnCore™ | 2022-10-24 SIZER SET 7620S DURAN ANCORE 26L CE |
| 00763000318482 - Contour 3D™ | 2022-07-11 SIZER SET 7690S CONTOUR 3D 26L CE |
| 00763000318345 - NA | 2021-07-27 HANDLE 7639 VALVE 26L CE |
Trademark Results [MOSAIC ULTRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOSAIC ULTRA 78470205 3294682 Live/Registered |
Medtronic, Inc. 2004-08-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.