AORTIC TRUE-SIZE OBTURATOR 27MM 116127MM

GUDID 00690103019391

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

Edwards Lifesciences LLC

Heart valve annulus sizer, reusable

• Primary Device ID: 00690103019391
• NIH Device Record Key: 50beb411-4f0b-4fc9-ae0a-618da4d54d79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AORTIC TRUE-SIZE OBTURATOR 27MM
• Version Model Number: 1161
• Catalog Number: 116127MM
• 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	00690103019391 [Primary]

FDA Product Code

• DTI: Sizer, Heart-Valve, Prosthesis

Sterilization

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

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

Moist Heat or Steam Sterilization

[00690103019391]

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

• 57460691952770 - TRUWAVE: 2026-03-30 PRESSURE MONITORING SET
• 57460691955887 - TRUWAVE: 2026-03-30 PRESSURE MONITORING SET
• 00690103000382 - SWAN-GANZ TRUE SIZE: 2026-03-24 SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
• 50690103218287 - SWAN-GANZ VIP: 2026-03-24 SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER
• 50690103218607 - SWAN-GANZ TRUE SIZE: 2026-03-24 TRUE SIZE THERMODILUTION CATHETER
• 50690103218621 - SWAN-GANZ TRUE SIZE: 2026-03-24 TRUE SIZE CATHETER DOUBLE LUMEN
• 50690103218638 - SWAN-GANZ TRUE SIZE: 2026-03-24 TRUE SIZE MONITORING CATHETER TRIPLE LUMEN
• 00690103221312 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 20 mm (Gen 2) (US)