LEEP PRECISION™ Integrated System

GUDID 00888937025101

LEEP PRECISION™ Integrated System (230 VAC)

Coopersurgical, Inc.

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• Primary Device ID: 00888937025101
• NIH Device Record Key: fc40146a-b2ec-422f-a50a-a1cb4dfb6064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEEP PRECISION™ Integrated System
• Version Model Number: LP-10-220
• 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	00888937025101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963348

FDA Product Code

• HGI: Electrocautery, Gynecologic (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-12
• Device Publish Date: 2023-01-04

On-Brand Devices [LEEP PRECISION™ Integrated System]

• 00888937014228: LEEP PRECISION™ Integrated System (120 VAC)
• 00888937025101: LEEP PRECISION™ Integrated System (230 VAC)