Carrera Loop Electrodes

Basic Information

• Brand Name: Carrera Loop Electrodes
• Primary DI: GYNXOCMR20101
• Version / Model: OCMR-2010
• Company Name: GYNEX CORPORATION
• Labeler DUNS: 012997685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-01-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9c39ac48-4243-463e-b6cf-0b3625f57a66

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45633	Electrocautery system electrode	An active conductor (e.g., blade or loop) that is attached to an electrocautery system handpiece or other surgical instrument (e.g., an endoscopic device) which is heated via the electrical current from the generator and used during surgical intervention to burn or sear body tissue. It is made of an appropriate metal and is typically used to stop bleeding (cauterization of blood vessels) and to treat superficial skin lesions (e.g., removal of warts). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	GYNXOCMR20101	HIBCC
Unit of Use	GYNXOCMR20100	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K982739	000