Radius Loop Electrodes

GUDID GYNX1210101

GYNEX CORPORATION

Electrocautery system electrode

• Primary Device ID: GYNX1210101
• NIH Device Record Key: 61a54e38-4d9b-4b16-b349-cd6fdc6c9c99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radius Loop Electrodes
• Version Model Number: 12-1010
• 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	GYNX10100 [Unit of Use]
HIBCC	GYNX1210101 [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: 2016-10-04

On-Brand Devices [Radius Loop Electrodes]

• GYNX1225151: 12-2515
• GYNX1225101: 12-2510
• GYNX1220151: 12-2015
• GYNX1220101: 12-2010
• GYNX1220081: 12-2008
• GYNX1215151: 12-1515
• GYNX1215121: 12-1512
• GYNX1215081: 12-1508
• GYNX1215051: 12-1505
• GYNX1210231: 12-2013
• GYNX1210101: 12-1010
• GYNX1210071: 12-1007
• GYNX1205051: 12-0505