Simulus™

GUDID 00763000318512

SIZER SET 750 SIMULUS FLEXIBLE 1L CE

MEDTRONIC 3F THERAPEUTICS, INC.

Heart valve sizer, reusable

• Primary Device ID: 00763000318512
• NIH Device Record Key: 7bfd98be-3c26-48cb-aff7-bb78917b3912
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simulus™
• Version Model Number: 750
• 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
• 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	00763000318512 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

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

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

Moist Heat or Steam Sterilization

[00763000318512]

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 [Simulus™]

• 00763000318543: SIZER SET 850 SEMI-RIDGID SIMULUS CE
• 00763000318536: HANDLE 752 SIMULUS ANNULOPLASTY CE
• 00763000318512: SIZER SET 750 SIMULUS FLEXIBLE 1L CE
• 00763000318529: SIZER SET 755 SIMULUS FLEXIBLEROBOTIC CE