| Primary Device ID | B49060060339 |
| NIH Device Record Key | bf519b7e-b184-4a74-9682-d5c58eb1af95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Carving Implant |
| Version Model Number | D |
| Catalog Number | 600-603-3-9 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B49060060339 [Primary] |
| MIB | Elastomer, Silicone Block |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B49060060339]
Dry Heat Sterilization
[B49060060339]
Dry Heat Sterilization
[B49060060339]
Dry Heat Sterilization
[B49060060339]
Dry Heat Sterilization
[B49060060339]
Dry Heat Sterilization
[B49060060339]
Dry Heat Sterilization
[B49060060339]
Dry Heat Sterilization
[B49060060339]
Dry Heat Sterilization
[B49060060339]
Dry Heat Sterilization
[B49060060339]
Dry Heat Sterilization
[B49060060339]
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 |
| B490600825 | Silicone Carving Implant Style 8 Size 25 |
| B490600820 | Silicone Carving Implant Style 8 Size 20 |
| B490600804 | Silicone Carving Implant Style 8 Size 4 |
| B490600803 | Silicone Carving Implant Style 8 Size 3 |
| B490600802 | Silicone Carving Implant Style 8 Size 2 |
| B490600801 | Silicone Carving Implant Style 8 Size 1 |
| B4906006059 | Silicone Carving Implant Style 6 Size 5 with Suture Tabs |
| B49060060539 | Silicone Carving Implant Style 6 Size 5, Smooth with Suture Tabs |
| B490600605 | Silicone Carving Implant Style 6 Size 5 |
| B4906006049 | Silicone Carving Implant Style 6 Size 4 with Suture Tabs |
| B49060060439 | Silicone Carving Implant Style 6 Size 4, Smooth with Suture Tabs |
| B490600604 | Silicone Carving Implant Style 6 Size 4 |
| B4906006039 | Silicone Carving Implant Style 6 Size 3 with Suture Tabs |
| B49060060339 | Silicone Carving Implant Style 6 Size 3, Smooth with Suture Tabs |
| B490600603 | Silicone Carving Implant Style 6 Size 3 |
| B4906006029 | Silicone Carving Implant Style 6 Size 2 with Suture Tabs |
| B49060060239 | Silicone Carving Implant Style 6 Size 2, Smooth with Suture Tabs |
| B490600602 | Silicone Carving Implant Style 6 Size 2 |
| B4906006019 | Silicone Carving Implant Style 6 Size 1 with Suture Tabs |
| B49060060139 | Silicone Carving Implant Style 6 Size 1, Smooth with Suture Tabs |
| B490600601 | Silicone Carving Implant Style 6 Size 1 |