Primary Device ID | 10816417020558 |
NIH Device Record Key | c26af5a4-ba62-4cf5-b482-d1ac47cc68f2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CoolSmooth Securement System |
Version Model Number | BRZ-SS2-09X-012 |
Catalog Number | BRZ-SS2-09X-012 |
Company DUNS | 809152916 |
Company Name | Zeltiq Aesthetics, Inc. |
Device Count | 12 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com | |
Phone | 888-935-8471 |
support@zeltiq.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816417020551 [Unit of Use] |
GS1 | 10816417020558 [Primary] |
OOK | Dermal Cooling Pack/Vacuum/Massager |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2025-06-30 |
Device Publish Date | 2016-09-23 |
10816417020558 | CoolSmooth Securement Strap, Short, Qty |
10816417020541 | Securement System, Qty 12 |