CoolSculpting Control Unit BRZ-CG1-CUD-110

GUDID 00816417020001

Base Module

Zeltiq Aesthetics, Inc.

Cryolipolysis body contouring system control unit

• Primary Device ID: 00816417020001
• NIH Device Record Key: 702f4b5c-d08c-4bfd-a087-3be60639a635
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoolSculpting Control Unit
• Version Model Number: BRZ-CG1-CUD-110
• Catalog Number: BRZ-CG1-CUD-110
• Company DUNS: 809152916
• Company Name: Zeltiq Aesthetics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-935-8471
• Email: support@zeltiq.com
• Phone: 888-935-8471
• Email: support@zeltiq.com
• Phone: 888-935-8471
• Email: support@zeltiq.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816417020001 [Primary]

FDA Product Code

• OOK: Dermal Cooling Pack/Vacuum/Massager

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-13

Devices Manufactured by Zeltiq Aesthetics, Inc.

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• 00816417021008 - CoolCurve Applicator: 2021-08-20 CoolCurve Applicator
• 00816417021329 - CoolSculpting Applicator Cable Support Arm: 2021-08-16 Applicator Cable Support Arm
• 00816417021350 - CoolAdvantage Petite Comfort Strap: 2021-08-16 CoolAdvantage Petite Comfort Strap
• 00816417022739 - CoolMini Support Arm System: 2021-08-16 Support Arm System, CoolMini
• 00816417023064 - CoolMini Securement Straps: 2021-08-16 Assembly, Pouched Securement Straps, CoolMini
• 00816417022586 - CoolSculpting Umbilical Cable Assembly 2.3m: 2021-06-23 CoolSculpting Umbilical Cable Assembly 2.3m
• 00816417022593 - CoolSculpting Umbilical Cable Assembly 2.6m: 2021-06-23 CoolSculpting Umbilical Cable Assembly 2.6m