CoolAdhesive Gel Pad (Medium)

Basic Information

• Brand Name: CoolAdhesive Gel Pad (Medium)
• Primary DI: 00816417021497
• Version / Model: CS-GL-MED-10-00
• Company Name: Zeltiq Aesthetics, Inc.
• Labeler DUNS: 809152916
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 1
• Public Version Date: 2020-09-08
• Public Version Status: New
• Public Device Record Key: be97be64-9aba-4569-b5d7-1d1d7f8edf64

Device Description

CoolAdhesive Gel Pad (Medium) package contains ten pads. Package represents the lowest marketed level.

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
56311	Cryolipolysis body contouring system gel pad	A non-sterile component of a cryolipolysis body contouring system designed to be applied to the skin of a patient to convey cold energy at the interface between the system’s applicator and the treatment site on the patient during cold-assisted lipolysis treatment (coolsculpting). It consists of a coupling gel in an envelope of thin material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816417021497	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181740	000