| Primary Device ID | B4904012025 |
| NIH Device Record Key | 7bf42954-49e9-4b22-b5b5-afd42a3b0c56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Malar Implant |
| Version Model Number | D |
| Catalog Number | 401-202-5 |
| Company DUNS | 091356894 |
| Company Name | Aart |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com | |
| Phone | (775) 853-6800 |
| customer.service@alphaaesthetics.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B4904012025 [Primary] |
| LZK | Implant, Malar |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
[B4904012025]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-05 |
| Device Publish Date | 2025-08-28 |
| B4904012026 | Malar Style 2 Size 2 Right |
| B4904012025 | Malar Style 2 Size 2 Left |
| B4904012016 | Malar Style 2 Size 1 Right |
| B4904012015 | Malar Style 2 Size 1 Left |
| B4904011036 | Malar Style 1 Size 3 Right |
| B4904011035 | Malar Style 1 Size 3 Left |
| B4904011026 | Malar Style 1 Size 2 Right |
| B4904011025 | Malar Style 1 Size 2 Left |
| B4904011016 | Malar Style 1 Size 1 Right |
| B4904011015 | Malar Style 1 Size 1 Left |