COOLIEF* Cooled RF Introducer

Basic Information

• Brand Name: COOLIEF* Cooled RF Introducer
• Primary DI: 10680651442076
• Version / Model: 44207
• Catalog Number: CRI-17-75-5.5
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 6
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 3d785c98-3f46-4322-ac9f-7755ff463f22

Device Description

Coolief* Cooled Radiofrequency Introducer

Device Characteristics

• Single Use: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXI	PROBE, RADIOFREQUENCY LESION	Neurology	882.4725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48802	Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Ross River virus (RRV) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10680651442076	GS1

Customer Contacts

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