CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE BARREL SIZER 1173B

GUDID 00690103186383

CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE BARREL SIZER

Edwards Lifesciences LLC

Heart valve annulus sizer, reusable

• Primary Device ID: 00690103186383
• NIH Device Record Key: 53c4c7d8-85ab-4ded-b223-106eb348cf50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE BARREL SIZER
• Version Model Number: 1173B
• Catalog Number: 1173B
• 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
• 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	00690103186383 [Primary]

FDA Product Code

• DTI: Sizer, Heart-Valve, Prosthesis

Sterilization

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

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

[00690103186383]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-18
• Device Publish Date: 2026-02-10

Devices Manufactured by Edwards Lifesciences LLC

• 00690103221312 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 20 mm (Gen 2) (US)
• 00690103221329 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 23 mm (Gen 2) (US)
• 00690103221336 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 26 mm (Gen 2) (US)
• 00690103221343 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 29 mm (Gen 2) (US)
• 00690103019353 - AORTIC TRUE-SIZE OBTURATOR 19MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019360 - AORTIC TRUE-SIZE OBTURATOR 21MM: 2026-02-23 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