SAFE® System Surgical Smoke Evacuator 10000

GUDID 00850043007067

EDGE SYSTEMS LLC

Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system 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