| Primary Device ID | B4905002016 |
| NIH Device Record Key | 575277c7-b1a5-4866-8064-1cfcf7f1225e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pectoral Implant |
| Version Model Number | E |
| Catalog Number | 500-201-6 |
| 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 | B4905002016 [Primary] |
| MIC | Implant, Muscle, Pectoralis |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
[B4905002016]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-08 |
| Device Publish Date | 2025-08-29 |
| B49050020153 | Pectoral Style 2 Size 1 Left, Smooth |
| B4905002015 | Pectoral Style 2 Size 1 Left |
| B49050020063 | Pectoral Style 2 Size 0 Right, Smooth |
| B4905002006 | Pectoral Style 2 Size 0 Right |
| B49050020053 | Pectoral Style 2 Size 0 Left, Smooth |
| B4905002005 | Pectoral Style 2 Size 0 Left |
| B4905001066 | Pectoral Style 1 Size 6 Right |
| B4905001065 | Pectoral Style 1 Size 6 Left |
| B4905001056 | Pectoral Style 1 Size 5 Right |
| B4905001055 | Pectoral Style 1 Size 5 Left |
| B4905001046 | Pectoral Style 1 Size 4 Right |
| B4905001045 | Pectoral Style 1 Size 4 Left |
| B4905001036 | Pectoral Style 1 Size 3 Right |
| B4905001035 | Pectoral Style 1 Size 3 Left |
| B4905001026 | Pectoral Style 1 Size 2 Right |
| B4905001025 | Pectoral Style 1 Size 2 Left |
| B4905001016 | Pectoral Style 1 Size 1 Right |
| B4905001015 | Pectoral Style 1 Size 1 Left |
| B4905004046 | Pectoral Style 4 Size 4 Right |
| B4905004045 | Pectoral Style 4 Size 4 Left |
| B4905004036 | Pectoral Style 4 Size 3 Right |
| B4905004035 | Pectoral Style 4 Size 3 Left |
| B4905004026 | Pectoral Style 4 Size 2 Right |
| B4905004025 | Pectoral Style 4 Size 2 Left |
| B4905004016 | Pectoral Style 4 Size 1 Right |
| B4905004015 | Pectoral Style 4 Size 1 Left |
| B4905003026 | Pectoral Style 3 Size 2 Right |
| B4905003025 | Pectoral Style 3 Size 2 Left |
| B4905003016 | Pectoral Style 3 Size 1 Right |
| B4905003015 | Pectoral Style 3 Size 1 Left |
| B4905002036 | Pectoral Style 2 Size 3 Right |
| B4905002035 | Pectoral Style 2 Size 3 Left |
| B4905002026 | Pectoral Style 2 Size 2 Right |
| B4905002025 | Pectoral Style 2 Size 2 Left |
| B49050020163 | Pectoral Style 2 Size 1 Right, Smooth |
| B4905002016 | Pectoral Style 2 Size 1 Right |