Profile 3D™

GUDID 00763000318505

SIZER SET 7680S PROFILE 3D 26L CE

MEDTRONIC, INC.

Heart valve annulus sizer, reusable

• Primary Device ID: 00763000318505
• NIH Device Record Key: 60c688da-ea65-4112-aa4b-c241b1e1d1d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profile 3D™
• Version Model Number: 7680S
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000318505 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

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

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

[00763000318505]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-21
• Device Publish Date: 2023-11-13

On-Brand Devices [Profile 3D™]

• 00613994749437: RING 680R36 PROFILE 3D 26L INSERT
• 00613994749420: RING 680R34 PROFILE 3D 26L INSERT
• 00613994749413: RING 680R32 PROFILE 3D 26L INSERT
• 00613994749406: RING 680R30 PROFILE 3D 26L INSERT
• 00613994749390: RING 680R28 PROFILE 3D 26L INSERT
• 00613994749383: RING 680R26 PROFILE 3D 26L INSERT
• 00613994749376: RING 680R24 PROFILE 3D 26L INSERT
• 00613994410344: RING 680R26 PROFILE 3D 26L
• 00613994410337: RING 680R32 PROFILE 3D 26L
• 00613994410313: RING 680R28 PROFILE 3D 26L
• 00613994410306: RING 680R30 PROFILE 3D 26L
• 00613994410283: RING 680R38 PROFILE 3D 26L
• 00763000318505: SIZER SET 7680S PROFILE 3D 26L CE