SAFE® System Surgical Smoke Evacuator 10000

GUDID 00850043007067

EDGE SYSTEMS LLC

Surgical plume evacuation system

• Primary Device ID: 00850043007067
• NIH Device Record Key: 46a5ac8e-389c-4166-932f-f4ad55af5b14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAFE® System Surgical Smoke Evacuator
• Version Model Number: 10000
• Catalog Number: 10000
• Company DUNS: 364134791
• Company Name: EDGE SYSTEMS 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com
• Phone: 800-603-4996
• Email: contact@edgeforlife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850043007067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880890

FDA Product Code

• FYD: Apparatus, Exhaust, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by EDGE SYSTEMS LLC

• 00850043007005 - Del Sol Red Light Therapy System: 2020-02-24 Red Cordless LED - US
• 00850043007029 - Del Sol Red Light Therapy System: 2020-02-24 Red LED Handpiece, 12V
• 00850043007043 - Del Sol Red Light Therapy System: 2020-02-24 Red LED Handpiece with Power Supply
• 00850043007340 - Del Sol Red Light Therapy System: 2020-02-24 Del Sol Red Cordless LED Light for EU/CE only
• 00850043007012 - Del Sol Blue Light Therapy System: 2018-07-06 Blue Cordless LED - US
• 00850043007036 - Del Sol Blue Light Therapy System: 2018-07-06 Blue LED Handpiece, 5V
• 00850043007050 - Del Sol Blue Light Therapy System: 2018-07-06 Blue LED Handpiece with Power Supply
• 00850043007067 - SAFE® System Surgical Smoke Evacuator: 2018-07-06
• 00850043007067 - SAFE® System Surgical Smoke Evacuator: 2018-07-06