HEART VALVE ACCESSOR 1117

GUDID 00690103166989

MITRAL SIZER HANDLE

Edwards Lifesciences LLC

Heart valve prosthesis holder, reusable

• Primary Device ID: 00690103166989
• NIH Device Record Key: 07453840-a0f6-4430-8146-f637e0db50e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEART VALVE ACCESSOR
• Version Model Number: 1117
• Catalog Number: 1117
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103166989 [Primary]

FDA Product Code

• DTJ: Holder, Heart-Valve, Prosthesis

Sterilization

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

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

[00690103166989]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-28
• Device Publish Date: 2024-10-18

On-Brand Devices [HEART VALVE ACCESSOR]

• 00690103166989: MITRAL SIZER HANDLE
• 00690103019339: HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S