CoolSmooth Liner

Basic Information

• Brand Name: CoolSmooth Liner
• Primary DI: 10816417020732
• Version / Model: BRZ-LN1-09X-024
• Catalog Number: BRZ-LN1-09X-024
• Company Name: Zeltiq Aesthetics, Inc.
• Labeler DUNS: 809152916
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ab5f9859-5ac8-4796-9b4c-2ac19895e497

Device Description

CoolSmooth Liner, Qty 24

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	878.4340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56310	Cryolipolysis body contouring system applicator liner	A non-sterile cover designed to provide a hygienic barrier between the contact surface of a cryolipolysis body contouring system applicator and a dedicated gel pad placed on the surface of a patient's skin during cold-assisted lipolysis treatment (coolsculpting). It is typically made of disposable plastic material (e.g., a thin plastic) and may be shaped to fit the applicator head. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816417020732	GS1
Unit of Use	00816417020735	GS1

Customer Contacts

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