S150 Liner

Basic Information

• Brand Name: S150 Liner
• Primary DI: 00816417022319
• Version / Model: CS-LI-15S-01-00
• Catalog Number: CS-LI-15S-01-00
• Company Name: Zeltiq Aesthetics, Inc.
• Labeler DUNS: 809152916
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 1
• Public Version Date: 2020-12-17
• Public Version Status: New
• Public Device Record Key: 440dd54b-2dca-4967-8df1-c6a7ab2349d0

Device Description

Foam Borders,S150 Applicator

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	00816417022319	GS1

Customer Contacts

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