GUDID 00763000318352

HANDLE 7639XL VALVE XL 26L CE

MEDTRONIC 3F THERAPEUTICS, INC.

Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle

• Primary Device ID: 00763000318352
• NIH Device Record Key: 3a22fd91-d3ee-42ef-b1f4-c370090bae12
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 7639XL
• 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

Device Dimensions

• Length: 368 Millimeter
• Length: 368 Millimeter
• Length: 368 Millimeter
• Length: 368 Millimeter
• Length: 368 Millimeter
• Length: 368 Millimeter
• Length: 368 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000318352 [Primary]

FDA Product Code

• DTJ: HOLDER, HEART-VALVE, PROSTHESIS

Sterilization

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

[00763000318352]

Moist Heat or Steam Sterilization

[00763000318352]

Moist Heat or Steam Sterilization

[00763000318352]

Moist Heat or Steam Sterilization

[00763000318352]

Moist Heat or Steam Sterilization

[00763000318352]

Moist Heat or Steam Sterilization

[00763000318352]

Moist Heat or Steam Sterilization

[00763000318352]

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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• 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
• 00763000318352 - NA: 2021-07-27HANDLE 7639XL VALVE XL 26L CE
• 00763000318352 - NA: 2021-07-27 HANDLE 7639XL VALVE XL 26L CE
• 00763000318437 - NA: 2021-07-27 HANDLE 7615 ANNULOPLASTY 26L CE