| Primary Device ID | 00812790023325 |
| NIH Device Record Key | 79000a9f-9477-4fdb-b9a8-cdba8abc6c88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIENTRA Malar Implant |
| Version Model Number | 25-40EU |
| Catalog Number | 25-40EU |
| Company DUNS | 010209877 |
| Company Name | Sientra, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812790023325 [Primary] |
| LZK | Implant, Malar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-23 |
| 00812790023349 | Malar Implant, Solid Silicone, Anatomical, Smooth, Left, 50 mm |
| 00812790023332 | Malar Implant, Solid Silicone, Anatomical, Smooth, Left, 43 mm |
| 00812790023325 | Malar Implant, Solid Silicone, Anatomical, Smooth, Left, 40 mm |
| 00812790023318 | Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 50 mm |
| 00812790023301 | Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 43 mm |
| 00812790023295 | Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 40 mm |