| Primary Device ID | B4904011016B0 |
| NIH Device Record Key | 605b1c99-8da1-4c5b-a154-6e49f7f5f592 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AART Malar Implant |
| Version Model Number | B |
| Catalog Number | 401-101-6B |
| 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 | false |
| 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 | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net | |
| Phone | +1(775)853-6800 |
| customer.service@aartinc.net |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B4904011016B0 [Primary] |
| LZK | IMPLANT, MALAR |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
[B4904011016B0]
Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-20 |
| B490401202A0 | Malar Sty 2 Sz 2 L&R Sterile |
| B4904012026B0 | Malar Sty 2 Sz 2 R Sterile |
| B4904012026A0 | Malar Sty 2 Sz 2 R Sterile |
| B4904012025B0 | Malar Sty 2 Sz 2 L Sterile |
| B4904012025A0 | Malar Sty 2 Sz 2 L Sterile |
| B490401201A0 | Malar Sty 1 Sz 2 L&R Sterile |
| B4904012016B0 | Malar Sty 2 Sz 1 R Sterile |
| B4904012016A0 | Malar Sty 2 Sz 1 R Sterile |
| B4904012015B0 | Malar Sty 2 Sz 1 L Sterile |
| B4904012015A0 | Malar Sty 2 Sz 1 L Sterile |
| B490401103A0 | Malar Sty 1 Sz 3 L &.R Sterile |
| B4904011036B0 | Malar Sty 1 Sz 3 R Sterile |
| B4904011036A0 | Malar Sty 1 Sz 3 R Sterile |
| B4904011035B0 | Malar Sty 1 Sz 3 L Sterile |
| B4904011035A0 | Malar Sty 1 Sz 3 L Sterile |
| B490401102A0 | Malar Sty 1 Sz 2 L&R Sterile |
| B4904011026B0 | Malar Sty 1 Sz 2 R Sterile |
| B4904011026A0 | Malar Sty 1 Sz 2 R Sterile |
| B4904011025B0 | Malar Sty 1 Sz 2 L Sterile |
| B4904011025A0 | Malar Sty 1 Sz 2 L Sterile |
| B490401101A0 | Malar Sty 1 Sz 1 L&R Sterile |
| B4904011016B0 | Malar Sty 1 Sz 1 R Sterile |
| B4904011016A0 | Malar Sty 1 Sz 1 R Sterile |
| B4904011015B0 | Malar Sty 1 Sz 1 L Sterile |
| B4904011015A0 | Malar Sty 1 Sz 1 L Sterile |