Pretreatment Skin Wipe BRZ-PSW-000-024

GUDID 10816417020114

Pretreatment Skin Wipes

Zeltiq Aesthetics, Inc.

Cryolipolysis body contouring system
Primary Device ID10816417020114
NIH Device Record Key7ce61b41-fc75-4ec5-a947-fd29106a6215
Commercial Distribution StatusIn Commercial Distribution
Brand NamePretreatment Skin Wipe
Version Model NumberBRZ-PSW-000-024
Catalog NumberBRZ-PSW-000-024
Company DUNS809152916
Company NameZeltiq Aesthetics, Inc.
Device Count24
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
GS100816417020117 [Unit of Use]
GS110816417020114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2020-05-18
Device Publish Date2016-09-23

Devices Manufactured by Zeltiq Aesthetics, Inc.

00816417022746 - Curve 135 (C135) Applicator2024-04-03 CoolSculpting System Applicator Curve 135 (C135)
00816417021008 - CoolCurve Applicator2021-08-20 CoolCurve Applicator
00816417021329 - CoolSculpting Applicator Cable Support Arm2021-08-16 Applicator Cable Support Arm
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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