| Primary Device ID | 00078301921133 |
| NIH Device Record Key | 6283418a-4f2c-4098-8c93-2a7c229c2408 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Couture Essence |
| Version Model Number | Thigh |
| Catalog Number | 921113 |
| Company DUNS | 061789731 |
| Company Name | Carolon Company |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |