GUDID 00763000318444

HANDLE 7615XL ANNULOPLASTY XL 26L CE

MEDTRONIC 3F THERAPEUTICS, INC.

Heart valve prosthesis sizer handle

• Primary Device ID: 00763000318444
• NIH Device Record Key: dbc5406c-b3e3-41d8-b66b-e25e1a2a1b03
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 7615XL
• 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

Device Dimensions

• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter
• Length: 373 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000318444 [Primary]

FDA Product Code

• DTJ: HOLDER, HEART-VALVE, PROSTHESIS

Sterilization

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

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

[00763000318444]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-27
• Device Publish Date: 2021-07-19

Devices Manufactured by MEDTRONIC 3F THERAPEUTICS, INC.

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• 00763000318383 - MOSAIC™: 2024-08-19 SIZERS 7308C MOSAIC AORTIC 26L CE
• 00885074426815 - Duran AnCore®: 2024-03-18 TOOL 7620H HANDLE DURAN ANCORE 14L
• 00643169402546 - HANCOCK II ULTRA™ SUPRA-X™: 2023-09-26 SIZERS 7505UX HKII ULT SUPRA-X AOR 26L
• 00763000318451 - CG Future™: 2023-02-13 SIZER SET 7638S CG FUTURE 26L CE
• 00763000318499 - Duran AnCore™: 2022-10-24 SIZER SET 7620S DURAN ANCORE 26L CE
• 00763000318482 - Contour 3D™: 2022-07-11 SIZER SET 7690S CONTOUR 3D 26L CE
• 00763000318345 - NA: 2021-07-27 HANDLE 7639 VALVE 26L CE