AORTIC TRUE-SIZE OBTURATOR 21MM 116121MM

GUDID 00690103019360

AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE

Edwards Lifesciences LLC

Heart valve annulus sizer, reusable

• Primary Device ID: 00690103019360
• NIH Device Record Key: 8a762753-e6f2-42c7-8285-9397792e7931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AORTIC TRUE-SIZE OBTURATOR 21MM
• Version Model Number: 1161
• Catalog Number: 116121MM
• 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)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103019360 [Primary]

FDA Product Code

• DTI: Sizer, Heart-Valve, Prosthesis

Sterilization

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

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

[00690103019360]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-23
• Device Publish Date: 2026-02-13

Devices Manufactured by Edwards Lifesciences LLC

• 00690103019353 - AORTIC TRUE-SIZE OBTURATOR 19MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019360 - AORTIC TRUE-SIZE OBTURATOR 21MM: 2026-02-23AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019360 - AORTIC TRUE-SIZE OBTURATOR 21MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019377 - AORTIC TRUE-SIZE OBTURATOR 23MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019384 - AORTIC TRUE-SIZE OBTURATOR 25MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019391 - AORTIC TRUE-SIZE OBTURATOR 27MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019407 - AORTIC TRUE-SIZE OBTURATOR 29MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019414 - AORTIC TRUE-SIZE OBTURATOR 31MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019278 - HEART VALVE SIZER ACCESSORY: 2026-02-19 CARPENTIER-EDWARDS AORTIC OBTURATOR