CoolAdhesive Gel Pad (Large)

GUDID 00816417021503

CoolAdhesive Gel Pad (Large) package contains 10 pads and is the lowest marketed level.

Zeltiq Aesthetics, Inc.

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Primary Device ID00816417021503
NIH Device Record Key67c658d3-033e-4dbf-bf92-c8a2124f8e5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoolAdhesive Gel Pad (Large)
Version Model NumberCS-GL-LRG-10-00
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 Usetrue
Lot Batchtrue
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
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com
Phone888-935-8471
Emailsupport@zeltiq.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816417021503 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-08
Device Publish Date2020-08-31

Devices Manufactured by Zeltiq Aesthetics, Inc.

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
00816417021664 - CoolSculpting Securement System Straps-Small2021-05-10 CoolSculpting Securement System Straps-Small

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