CoolSmooth PRO Securement Straps BRZ-SS3-09X-012

GUDID 10816417020565

Assembly Pouched Securement Straps, CoolSmooth

Zeltiq Aesthetics, Inc.

Cryolipolysis skin/body contouring system
Primary Device ID10816417020565
NIH Device Record Keya005a4a8-e7d3-4f0d-a823-0945bac4cd7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoolSmooth PRO Securement Straps
Version Model NumberBRZ-SS3-09X-012
Catalog NumberBRZ-SS3-09X-012
Company DUNS809152916
Company NameZeltiq Aesthetics, Inc.
Device Count2
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 Numberfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816417020568 [Unit of Use]
GS110816417020565 [Primary]

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 Date2025-06-30
Device Publish Date2016-09-23

Devices Manufactured by Zeltiq Aesthetics, Inc.

10816417020152 - CoolSmooth Foam Borders2025-06-30 CoolSmooth Foam Borders
10816417020541 - CoolSmooth Securement System2025-06-30 Securement System, Qty 12
10816417020558 - CoolSmooth Securement System2025-06-30 CoolSmooth Securement Strap, Short, Qty
10816417020565 - CoolSmooth PRO Securement Straps2025-06-30Assembly Pouched Securement Straps, CoolSmooth
10816417020565 - CoolSmooth PRO Securement Straps2025-06-30 Assembly Pouched Securement Straps, CoolSmooth
10816417020671 - CoolAdvantage Gasket2025-06-30 Gasket, 24-Pack, CoolAdvantage
10816417020916 - CoolAdvantage Petite Gasket - 24 Pack2025-06-30 CoolAdvantage Petite Gasket - 24 Pack
00816417022746 - Curve 135 (C135) Applicator2024-04-03 CoolSculpting System Applicator Curve 135 (C135)
00816417021008 - CoolCurve Applicator2021-08-20 CoolCurve Applicator

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.