GUDID 00763000613648

HANDLE 7639 VALVE MDR

MEDTRONIC, INC.

Heart valve prosthesis sizer handle

• Primary Device ID: 00763000613648
• NIH Device Record Key: 76863a1a-3538-435f-b887-7f7da0f2244f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 7639
• 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
• 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 Dimensions

• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter
• Length: 234 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000613648 [Primary]

FDA Product Code

• DTJ: HOLDER, HEART-VALVE, PROSTHESIS

Sterilization

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

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

[00763000613648]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-11
• Device Publish Date: 2025-03-03

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• 00763000659219 - SimuForm™: 2026-02-09 RING 7800RR26 SIMUFORM SR 26MM MDR
• 00763000659226 - SimuForm™: 2026-02-09 RING 7800RR28 SIMUFORM SR 28MM MDR
• 00763000659233 - SimuForm™: 2026-02-09 RING 7800RR30 SIMUFORM SR 30MM MDR
• 00763000659240 - SimuForm™: 2026-02-09 RING 7800RR32 SIMUFORM SR 32MM MDR
• 00763000659257 - SimuForm™: 2026-02-09 RING 7800RR34 SIMUFORM SR 34MM MDR
• 00763000659264 - SimuForm™: 2026-02-09 RING 7800RR36 SIMUFORM SR 36MM MDR