| Primary Device ID | 00816417021619 |
| NIH Device Record Key | b5e16267-0ad6-4402-a625-619b6cc5e7e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoolSculpting Elite Control Unit |
| Version Model Number | CS-S3-002-D-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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816417021619 [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 |