| Primary Device ID | 00763000318369 |
| NIH Device Record Key | 749c9ba7-a38e-4eb6-815c-cadfd7acfc32 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 7642 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000318369 [Primary] |
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
[00763000318369]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-09 |
| Device Publish Date | 2021-04-01 |
| 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 |