EDWARDS CRIMPER 9600CRA

GUDID 00690103193978

Edwards Lifesciences LLC

Basic crimper Basic crimper

• Primary Device ID: 00690103193978
• NIH Device Record Key: fd9db834-5d97-498a-9334-016a710dfdcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDWARDS CRIMPER
• Version Model Number: 9600CR
• Catalog Number: 9600CRA
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103193978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140031

FDA Product Code

• NPU: Prosthesis, Mitral Valve, Percutaneously Delivered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-05

On-Brand Devices [EDWARDS CRIMPER]

• 00690103198331: 9600CR
• 00690103193978: 9600CR
• 00690103192063: 9350CR