Medtronic Open Pivot™

GUDID 00763000318581

HANDLE BENDABLE 569 OPHV 26L CE

MEDTRONIC 3F THERAPEUTICS, INC.

Heart valve prosthesis sizer handle

• Primary Device ID: 00763000318581
• NIH Device Record Key: 3585b022-9bb5-43c1-acc0-d0c0893299dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Open Pivot™
• Version Model Number: 569
• 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
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000318581 [Primary]

FDA Product Code

• DWS: INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

[00763000318581]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-09
• Device Publish Date: 2021-04-01

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