Pretreatment Skin Wipe

Basic Information

• Brand Name: Pretreatment Skin Wipe
• Primary DI: 10816417020114
• Version / Model: BRZ-PSW-000-024
• Catalog Number: BRZ-PSW-000-024
• 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: 3
• Public Version Date: 2020-05-18
• Public Version Status: Update
• Public Device Record Key: 7ce61b41-fc75-4ec5-a947-fd29106a6215

Device Description

Pretreatment Skin Wipes

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: No
• 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
62441	Cryolipolysis body contouring system	An assembly of devices designed to non-invasively apply cold to the skin and subcutaneous tissues for subcutaneous fat layer reduction through cold-assisted lipolysis (coolsculpting); it may additionally be used to provide local anaesthesia for procedures that produce minor discomfort. It primarily consists of a mains electricity (AC-powered) control unit to produce the thermal energy, and an applicator and gel pad to convey the thermal energy to the target area (e.g., chin, hips, abdomen, thighs); additional components may be included (e.g., disposable liner for the applicator, electronic program cards, pager).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816417020114	GS1
Unit of Use	00816417020117	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181740	000