DISPOSABLE HANDLE FOR VALVES/SIZERS 1126

GUDID 50690103019242

DISPOSABLE HANDLE FOR VALVES/SIZERS

Edwards Lifesciences LLC

Heart valve prosthesis holder, single-use

• Primary Device ID: 50690103019242
• NIH Device Record Key: 2201995c-df83-4238-9608-71012d2f3695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPOSABLE HANDLE FOR VALVES/SIZERS
• Version Model Number: 1126
• Catalog Number: 1126
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103019247 [Primary]
GS1	50690103019242 [Package]; Contains: 00690103019247; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• DTI: Sizer, Heart-Valve, Prosthesis

Sterilization

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

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

Devices Manufactured by Edwards Lifesciences LLC

• 00690103019278 - HEART VALVE SIZER ACCESSORY: 2026-02-19 CARPENTIER-EDWARDS AORTIC OBTURATOR
• 00690103019285 - HEART VALVE SIZER ACCESSORY: 2026-02-19 CARPENTIER-EDWARDS AORTIC OBTURATOR
• 00690103019292 - HEART VALVE SIZER ACCESSORY: 2026-02-19 CARPENTIER-EDWARDS AORTIC OBTURATOR
• 00690103174755 - HEART VALVE SIZER ACCESSORY: 2026-02-19 PERIMOUNT MAGNA SIZER
• 00690103174762 - HEART VALVE SIZER ACCESSORY: 2026-02-19 PERIMOUNT MAGNA SIZER
• 00690103174779 - HEART VALVE SIZER ACCESSORY: 2026-02-19 PERIMOUNT MAGNA SIZER
• 00690103174786 - HEART VALVE SIZER ACCESSORY: 2026-02-19 PERIMOUNT MAGNA SIZER
• 00690103174793 - HEART VALVE SIZER ACCESSORY: 2026-02-19 PERIMOUNT MAGNA SIZER