CoolAdhesive Mini Pad

Basic Information

• Brand Name: CoolAdhesive Mini Pad
• Primary DI: 10816417020992
• Version / Model: BRZ-GL1-020-008
• Catalog Number: BRZ-GL1-020-008
• Company Name: Zeltiq Aesthetics, Inc.
• Labeler DUNS: 809152916
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2017-01-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ea804504-4c25-4a98-94d2-3c81123c2f50

Device Description

CoolAdhesive Mini Pad - 8 Pack Carton

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	10816417020992	GS1
Unit of Use	00816417020995	GS1

Customer Contacts

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