LEEP PRECISION™ Generator

GUDID 00888937019926

LEEP PRECISION™ Generator (120 VAC)

Coopersurgical, Inc.

Electrosurgical system generator

• Primary Device ID: 00888937019926
• NIH Device Record Key: bed7a05a-15bd-41c1-ae4c-2690ad64326f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEEP PRECISION™ Generator
• Version Model Number: DMLP-20-120
• 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	00888937019926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963653

FDA Product Code

• HGI: Electrocautery, Gynecologic (And Accessories)

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: 2017-09-28

On-Brand Devices [LEEP PRECISION™ Generator]

• 00888937019926: LEEP PRECISION™ Generator (120 VAC)
• 00888937014235: LEEP PRECISION™ Generator (120 VAC)