COOLIEF* TRANDISCAL* Radiofrequency Therapy Cable

Basic Information

• Brand Name: COOLIEF* TRANDISCAL* Radiofrequency Therapy Cable
• Primary DI: 00193493473076
• Version / Model: TRX-CRG-TDP2
• Catalog Number: TRX-CRG-TDP2
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-16
• Public Version: 2
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 2f3e4b8d-57b5-4b72-a2fa-98e877ca9fbe

Device Description

Connector Cable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXD	Generator, lesion, radiofrequency	Neurology	882.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35041	Electrosurgical cable adaptor	A small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00193493473076	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K192491	000