CoolSculpting System Applicator Surface 150 (S150)

GUDID 00816417021718

CoolSculpting System Applicator Surface 150 (S150)

Zeltiq Aesthetics, Inc.

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Primary Device ID00816417021718
NIH Device Record Key94cd7829-466a-45df-b70c-e7eb6edfda63
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoolSculpting System Applicator Surface 150 (S150)
Version Model NumberCS-A3-15S-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 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
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
GS100816417021718 [Primary]
GS100816417021718 [Primary]
GS100816417021718 [Primary]
GS100816417021718 [Primary]
GS100816417021718 [Primary]
GS100816417021718 [Primary]
GS100816417021718 [Primary]
GS100816417021718 [Primary]

FDA Product Code

OOKDermal Cooling Pack/Vacuum/Massager
OOKDermal Cooling Pack/Vacuum/Massager
OOKDermal Cooling Pack/Vacuum/Massager
OOKDermal Cooling Pack/Vacuum/Massager
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-31

Devices Manufactured by Zeltiq Aesthetics, Inc.

00816417021718 - CoolSculpting System Applicator Surface 150 (S150)2020-11-09CoolSculpting System Applicator Surface 150 (S150)
00816417021718 - CoolSculpting System Applicator Surface 150 (S150)2020-11-09 CoolSculpting System Applicator Surface 150 (S150)
00816417021473 - CoolAdhesive Gel Pad (Small)2020-09-08 CoolAdhesive Gel Pad (Small) Package contains ten gel pads.
00816417021497 - CoolAdhesive Gel Pad (Medium)2020-09-08 CoolAdhesive Gel Pad (Medium) package contains ten pads. Package represents the lowest marketed level.
00816417021503 - CoolAdhesive Gel Pad (Large)2020-09-08 CoolAdhesive Gel Pad (Large) package contains 10 pads and is the lowest marketed level.
00816417021510 - Gel Trap C802020-09-08 Gel Trap C80
00816417021534 - Gel Trap V32020-09-08 Gel Trap V3
00816417021558 - CoolSculpting System Applicators Curve 80 (C80)2020-09-08 CoolSculpting System Applicators Curve 80 (C80)
00816417021565 - CoolSculpting System Applicator Curve 150 (C150)2020-09-08 CoolSculpting System Applicator Curve 150 (C150)

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