Carrera Ball Electrodes

GUDID GYNXOCMB2321

GYNEX CORPORATION

Electrocautery system electrode

• Primary Device ID: GYNXOCMB2321
• NIH Device Record Key: 2a8d414b-a1a8-4328-9daf-89476b54f391
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carrera Ball Electrodes
• Version Model Number: OCMB-2-3-2
• Company DUNS: 012997685
• Company Name: GYNEX CORPORATION
• Device Count: 5
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	GYNXOCMB2320 [Unit of Use]
HIBCC	GYNXOCMB2321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982739

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-19

On-Brand Devices [Carrera Ball Electrodes]

• GYNXOCMB2521: OCMB-2-5-2
• GYNXOCMB2321: OCMB-2-3-2