HANCOCK II ULTRA™ SUPRA-X™
GUDID 00643169402546
SIZERS 7505UX HKII ULT SUPRA-X AOR 26L
MEDTRONIC 3F THERAPEUTICS, INC.
Heart valve annulus sizer, reusable| Primary Device ID | 00643169402546 |
| NIH Device Record Key | 71c9a524-a057-4f5f-a481-29ed4fec8ae6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HANCOCK II ULTRA™ SUPRA-X™ |
| Version Model Number | 7505UX |
| 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169402546 [Primary] |
FDA Product Code
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
[00643169402546]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-26 |
| Device Publish Date | 2023-09-18 |
Devices Manufactured by MEDTRONIC 3F THERAPEUTICS, INC.
| 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™ | 2023-09-26SIZERS 7505UX HKII ULT SUPRA-X AOR 26L |
| 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 [HANCOCK II ULTRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HANCOCK II ULTRA 78470219 3395756 Live/Registered |
Medtronic, Inc. 2004-08-19 |
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