Sealed CoolMini Applicator

GUDID 00816417021190

Applicator, Sealed CoolMini (NRR)

Zeltiq Aesthetics, Inc.

Cryolipolysis body contouring system applicator
Primary Device ID00816417021190
NIH Device Record Key1069f5ec-b567-4a5d-8cdf-1b32423b651f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSealed CoolMini Applicator
Version Model NumberCS-300650
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816417021190 [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 Date2018-09-12
Device Publish Date2018-08-12

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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