Duran AnCore®
GUDID 00885074426815
TOOL 7620H HANDLE DURAN ANCORE 14L
MEDTRONIC 3F THERAPEUTICS, INC.
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 Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable| Primary Device ID | 00885074426815 |
| NIH Device Record Key | 485a494f-a57a-498e-a938-7970cc6e320a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duran AnCore® |
| Version Model Number | 7620H |
| 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
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
| Length | 8.5 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885074426815 [Primary] |
FDA Product Code
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
[00885074426815]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-18 |
| Device Publish Date | 2024-03-08 |
Devices Manufactured by MEDTRONIC 3F THERAPEUTICS, INC.
| 00885074426815 - Duran AnCore® | 2024-03-18TOOL 7620H HANDLE DURAN ANCORE 14L |
| 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 |
| 00763000318352 - NA | 2021-07-27 HANDLE 7639XL VALVE XL 26L CE |
| 00763000318437 - NA | 2021-07-27 HANDLE 7615 ANNULOPLASTY 26L CE |
Trademark Results [Duran AnCore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURAN ANCORE 78131413 2849287 Live/Registered |
MEDTRONIC INC. 2002-05-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.