CoolSculpting Umbilical Cable Assembly 2.6m

Basic Information

• Brand Name: CoolSculpting Umbilical Cable Assembly 2.6m
• Primary DI: 00816417022593
• Version / Model: CS-A3-UM4-00
• Catalog Number: CS-A3-UM4-00
• Company Name: Zeltiq Aesthetics, Inc.
• Labeler DUNS: 809152916
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-15
• Public Version: 1
• Public Version Date: 2021-06-23
• Public Version Status: New
• Public Device Record Key: 4395710c-ed10-413c-a88d-6475b75ed22f

Device Description

CoolSculpting Umbilical Cable Assembly 2.6m

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
56309	Cryolipolysis body contouring system applicator	A component of a cryolipolysis body contouring system designed to convey controlled cold from the system's control unit to the skin and subcutaneous tissues for cold-assisted lipolysis (coolsculpting). It is typically in the form of an articulated arm designed to hold a gel pad against the surface of the treatment site, and may also be used to apply vacuum to facilitate the treatment; optional pulsatile massage may also be applied. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816417022593	GS1

Customer Contacts

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