Medtronic Open Pivot™
GUDID 00763000318604
SIZER SET 578 OPHV AP-AP360 NITINOL26LCE
MEDTRONIC 3F THERAPEUTICS, INC.
Heart valve sizer, reusable| Primary Device ID | 00763000318604 |
| NIH Device Record Key | 963e9de6-77b0-4f4b-b274-e45b8d32fcbd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medtronic Open Pivot™ |
| Version Model Number | 578 |
| 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 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 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 | 00763000318604 [Primary] |
FDA Product Code
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
[00763000318604]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-14 |
| Device Publish Date | 2021-06-06 |
On-Brand Devices [Medtronic Open Pivot™]
| 00763000318581 | HANDLE BENDABLE 569 OPHV 26L CE |
| 00763000318604 | SIZER SET 578 OPHV AP-AP360 NITINOL26LCE |
| 00763000318598 | SIZER SET 577 OPHV STANDARD 26L CE |
| 00763000318550 | SIZER SET 576 OPHV NITINOL 26L CE |
Trademark Results [Medtronic Open Pivot]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDTRONIC OPEN PIVOT 85760168 4645652 Live/Registered |
Medtronic, Inc. 2012-10-22 |
 MEDTRONIC OPEN PIVOT 85752964 not registered Dead/Abandoned |
Medtronic, Inc. 2012-10-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.