Medtronic Open Pivot™

GUDID 00613994867988

ACCY 576 MHV SIZER SET

MEDTRONIC, INC.

Heart valve annulus sizer, reusable

• Primary Device ID: 00613994867988
• NIH Device Record Key: 4941360a-82d8-431f-ae62-8835d3d5434e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Open Pivot™
• Version Model Number: 576
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994867988 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

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

[00613994867988]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-30
• Device Publish Date: 2025-12-22

On-Brand Devices [Medtronic Open Pivot™]

• 00763000022044: ACCY 576 NITINOL SIZER SET
• 00643169624979: ACCY 576 OPMV SIZER SET
• 00613994867988: ACCY 576 MHV SIZER SET