FOGARTY SOFTJAW CSOFT12

GUDID 00690103044188

FOGARTY SPRING CLIPS 12MM

Edwards Lifesciences LLC

Vascular clamp, single-use

• Primary Device ID: 00690103044188
• NIH Device Record Key: 0cec757f-12f6-4630-9d60-8b1cbf531e0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOGARTY SOFTJAW
• Version Model Number: CSOFT12
• Catalog Number: CSOFT12
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 10
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

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	00690103044188 [Primary]
GS1	70690103044187 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832554

FDA Product Code

• DXC: CLAMP, VASCULAR

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: 2016-09-03

On-Brand Devices [FOGARTY SOFTJAW]

• 00690103045741: FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
• 00690103045734: FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
• 00690103045727: FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
• 00690103044621: LIGHTWEIGHT CLIPS AND CLAMPS
• 00690103044614: CLAMP,EDSLAB HANDLELESS 8MM DBLE SOFTJAW
• 00690103044317: FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
• 00690103044300: FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
• 00690103044294: FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
• 00690103044195: FOGARTY SPRING CLIPS 6MM
• 00690103044188: FOGARTY SPRING CLIPS 12MM