LEEP System 1000® Smoke Evacuation System

GUDID 00888937014440

LEEP System 1000® Smoke Evacuation System (110 VAC)

Coopersurgical, Inc.

Surgical plume evacuation system

• Primary Device ID: 00888937014440
• NIH Device Record Key: 9e7c844d-35f8-4d03-a253-93375499a8b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEEP System 1000® Smoke Evacuation System
• Version Model Number: 6080-2
• 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	00888937014440 [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: 2016-09-22

Devices Manufactured by Coopersurgical, Inc.

• 00888937018240 - Lone Star® IRI Delivery: 2024-07-01 Lone Star® IRI Delivery Tube Replacement
• 00888937026597 - LEEP PRECISION™ Smoke Evacuator: 2024-06-25 LEEP PRECISION™ Smoke Evacuator (230 VAC)
• 60888937027176 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027183 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027190 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027206 - ERPeak: 2024-04-18 IVD Sample kit
• 00888937026870 - Mara Console: 2024-03-21 Mara Console- Endometrial Ablation
• 00888937023817 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right