| Primary Device ID | B490501101 |
| NIH Device Record Key | a3b17355-d2a8-41dc-a927-967e2e329b31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gluteal Implant |
| Version Model Number | E |
| Catalog Number | 501-101 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B490501101 [Primary] |
| MIB | Elastomer, Silicone Block |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
[B490501101]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-10 |
| Device Publish Date | 2025-09-02 |
| B4905016043 | Gluteal Style 6 Size 4, Smooth |
| B490501604 | Gluteal Style 6 Size 4 |
| B4905016033 | Gluteal Style 6 Size 3, Smooth |
| B490501603 | Gluteal Style 6 Size 3 |
| B4905016023 | Gluteal Style 6 Size 2, Smooth |
| B490501602 | Gluteal Style 6 Size 2 |
| B490501601 | Gluteal Style 6 Size 1 |
| B4905013103 | Gluteal Style 3 Size 10, Smooth |
| B490501310 | Gluteal Style 3 Size 10 |
| B4905013093 | Gluteal Style 3 Size 9, Smooth |
| B490501309 | Gluteal Style 3 Size 9 |
| B4905013083 | Gluteal Style 3 Size 8, Smooth |
| B490501308 | Gluteal Style 3 Size 8 |
| B4905013073 | Gluteal Style 3 Size 7, Smooth |
| B490501307 | Gluteal Style 3 Size 7 |
| B4905013063 | Gluteal Style 3 Size 6, Smooth |
| B490501306 | Gluteal Style 3 Size 6 |
| B4905013053 | Gluteal Style 3 Size 5, Smooth |
| B490501305 | Gluteal Style 3 Size 5 |
| B4905013043 | Gluteal Style 3 Size 4, Smooth |
| B490501304 | Gluteal Style 3 Size 4 |
| B4905013033 | Gluteal Style 3 Size 3, Smooth |
| B490501303 | Gluteal Style 3 Size 3 |
| B4905013023 | Gluteal Style 3 Size 2, Smooth |
| B490501302 | Gluteal Style 3 Size 2 |
| B4905013013 | Gluteal Style 3 Size 1, Smooth |
| B490501301 | Gluteal Style 3 Size 1 |
| B4905013003 | Gluteal Style 3 Size 0, Smooth |
| B490501300 | Gluteal Style 3 Size 0 |
| B4905012063 | Gluteal Style 2 Size 6, Smooth |
| B490501206 | Gluteal Style 2 Size 6 |
| B490501205 | Gluteal Style 2 Size 5 |
| B490501204 | Gluteal Style 2 Size 4 |
| B490501203 | Gluteal Style 2 Size 3 |
| B490501202 | Gluteal Style 2 Size 2 |
| B490501201 | Gluteal Style 2 Size 1 |
| B4905011063 | Gluteal Style 1 Size 6, Smooth |
| B490501106 | Gluteal Style 1 Size 6 |
| B4905011053 | Gluteal Style 1 Size 3, Smooth |
| B490501105 | Gluteal Style 1 Size 5 |
| B490501104 | Gluteal Style 1 Size 4 |
| B490501103 | Gluteal Style 1 Size 3 |
| B490501102 | Gluteal Style 1 Size 2 |
| B490501101 | Gluteal Style 1 Size 1 |