LEEP PRECISION™ Smoke Evacuation System

GUDID 00888937019940

LEEP PRECISION™ Smoke Evacuation System (120 VAC)

Coopersurgical, Inc.

Surgical plume evacuation system

• Primary Device ID: 00888937019940
• NIH Device Record Key: a158ad6d-7ef4-492a-aebb-b60e4b6936fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEEP PRECISION™ Smoke Evacuation System
• Version Model Number: DM53502
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937019940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910377

FDA Product Code

• GCX: Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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: 2017-09-27

On-Brand Devices [LEEP PRECISION™ Smoke Evacuation System]

• 00888937019940: LEEP PRECISION™ Smoke Evacuation System (120 VAC)
• 00888937014242: LEEP PRECISION™ Smoke Evacuation System (120 VAC)