Primary Device ID | 00816417021589 |
NIH Device Record Key | 08ca7fcf-b785-417e-a738-4b9134e58cca |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CoolSculpting System Applicator Flat 125 (F125) |
Version Model Number | CS-A3-12F-00 |
Company DUNS | 809152916 |
Company Name | Zeltiq Aesthetics, Inc. |
Device Count | 1 |
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 | true |
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 | |
Phone | 888-935-8471 |
support@zeltiq.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816417021589 [Primary] |
OOK | Dermal Cooling Pack/Vacuum/Massager |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-08 |
Device Publish Date | 2020-08-31 |
00816417022746 - Curve 135 (C135) Applicator | 2024-04-03 CoolSculpting System Applicator Curve 135 (C135) |
00816417021008 - CoolCurve Applicator | 2021-08-20 CoolCurve Applicator |
00816417021329 - CoolSculpting Applicator Cable Support Arm | 2021-08-16 Applicator Cable Support Arm |
00816417021350 - CoolAdvantage Petite Comfort Strap | 2021-08-16 CoolAdvantage Petite Comfort Strap |
00816417022739 - CoolMini Support Arm System | 2021-08-16 Support Arm System, CoolMini |
00816417023064 - CoolMini Securement Straps | 2021-08-16 Assembly, Pouched Securement Straps, CoolMini |
00816417022586 - CoolSculpting Umbilical Cable Assembly 2.3m | 2021-06-23 CoolSculpting Umbilical Cable Assembly 2.3m |
00816417022593 - CoolSculpting Umbilical Cable Assembly 2.6m | 2021-06-23 CoolSculpting Umbilical Cable Assembly 2.6m |