CoolGel Mini BRZ-GS1-000-024

GUDID 10816417020091

CoolGel Mini Syringe - 24 Syringes In a Carton

Zeltiq Aesthetics, Inc.

Cryolipolysis body contouring system Cryolipolysis body contouring system Cryolipolysis body contouring system Cryolipolysis body contouring system
Primary Device ID10816417020091
NIH Device Record Keycfc0714b-77f2-4fa0-832d-096dbfdda83f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoolGel Mini
Version Model NumberBRZ-GS1-000-024
Catalog NumberBRZ-GS1-000-024
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816417020094 [Unit of Use]
GS100816417020094 [Unit of Use]
GS100816417020094 [Unit of Use]
GS100816417020094 [Unit of Use]
GS110816417020091 [Primary]
GS110816417020091 [Primary]
GS110816417020091 [Primary]
GS110816417020091 [Primary]

FDA Product Code

OOKDermal Cooling Pack/Vacuum/Massager
OOKDermal Cooling Pack/Vacuum/Massager
OOKDermal Cooling Pack/Vacuum/Massager
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 Date2020-05-21
Device Publish Date2016-09-23

Devices Manufactured by Zeltiq Aesthetics, Inc.

10816417020091 - CoolGel Mini2020-05-21CoolGel Mini Syringe - 24 Syringes In a Carton
10816417020091 - CoolGel Mini2020-05-21 CoolGel Mini Syringe - 24 Syringes In a Carton
10816417020084 - CoolMini Liner2020-05-18 CoolMini Liner
10816417020114 - Pretreatment Skin Wipe2020-05-18 Pretreatment Skin Wipes
10816417020947 - Pretreatment Skin Wipes2020-05-04 Pretreatment Skin Wipes 8 pack
00816417020537 - CoolSmooth PRO Securement Plate2020-05-04 Center Securement Plate, CoolSmooth PRO
00081641702102 - CoolAdvantage Petite Card2020-01-30 CoolAdvantage Petite Card, CD4, Direct, 3 Cycles
00816417021237 - CoolAdvantage Petite Core2019-11-15 CoolAdvantage Petite Core Applicator
00816417021244 - CoolAdvantage Core2019-11-15 CoolAdvantage Core Applicator

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