LEEP Macro Needle Electrode

GUDID 20888937010729

LEEP Macro Needle Electrode with 16mm Needle Electrode and 5.5cm Shaft

Coopersurgical, Inc.

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• Primary Device ID: 20888937010729
• NIH Device Record Key: c973c696-b400-4d39-9d19-94f54def83bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEEP Macro Needle Electrode
• Version Model Number: N0550
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937010725 [Primary]
GS1	20888937010729 [Package]; Contains: 00888937010725; 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: false

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 Macro Needle Electrode]

• 20888937010736: LEEP Macro Needle Electrode with 16mm Needle Electrode and 12cm Shaft
• 20888937010729: LEEP Macro Needle Electrode with 16mm Needle Electrode and 5.5cm Shaft