LEEP Ball Electrode

GUDID 20888937010903

LEEP Ball Electrode; 3mm Diameter and 12cm Shaft

Coopersurgical, Inc.

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 20888937010903
• NIH Device Record Key: 404d6064-dce8-488b-8459-5b8991227854
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEEP Ball Electrode
• Version Model Number: B0312
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00888937010909 [Primary]
GS1	20888937010903 [Package]; Contains: 00888937010909; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905747

FDA Product Code

• HGI: Electrocautery, Gynecologic (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-08-15

On-Brand Devices [LEEP Ball Electrode]

• 20888937010910: LEEP Ball Electrode; 5mm Diameter; 12cm Shaft
• 20888937010903: LEEP Ball Electrode; 3mm Diameter and 12cm Shaft
• 20888937010712: LEEP Ball Electrode; 5mm Diameter; 5.5cm Shaft