CoolSculpting Base Module BRZ-CG1-BAM-110

GUDID 00816417020025

Control Unit

Zeltiq Aesthetics, Inc.

Cryolipolysis body contouring system control unit Cryolipolysis body contouring system control unit Cryolipolysis body contouring system control unit
Primary Device ID00816417020025
NIH Device Record Key634f3c84-9abf-407b-9efa-fad95ba9de85
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoolSculpting Base Module
Version Model NumberBRZ-CG1-BAM-110
Catalog NumberBRZ-CG1-BAM-110
Company DUNS809152916
Company NameZeltiq Aesthetics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816417020025 [Primary]

FDA Product Code

OOKDermal Cooling Pack/Vacuum/Massager

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-13

Devices Manufactured by Zeltiq Aesthetics, Inc.

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00816417021350 - CoolAdvantage Petite Comfort Strap2021-08-16 CoolAdvantage Petite Comfort Strap
00816417022739 - CoolMini Support Arm System2021-08-16 Support Arm System, CoolMini
00816417023064 - CoolMini Securement Straps2021-08-16 Assembly, Pouched Securement Straps, CoolMini
00816417022586 - CoolSculpting Umbilical Cable Assembly 2.3m2021-06-23 CoolSculpting Umbilical Cable Assembly 2.3m
00816417022593 - CoolSculpting Umbilical Cable Assembly 2.6m2021-06-23 CoolSculpting Umbilical Cable Assembly 2.6m

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