| Primary Device ID | B040ARC8 |
| NIH Device Record Key | c834c9b0-c9fb-492c-b8de-4130fe333a6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aortic Repair Caliper |
| Version Model Number | ARC-8 |
| Company DUNS | 939872651 |
| Company Name | GENESEE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B040ARC8 [Package] Contains: B040ARC80 Package: [1 Units] In Commercial Distribution |
| HIBCC | B040ARC80 [Primary] |
| DWS | Instruments, Surgical, Cardiovascular |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B040ARC8]
Moist Heat or Steam Sterilization
[B040ARC8]
Moist Heat or Steam Sterilization
[B040ARC8]
Moist Heat or Steam Sterilization
[B040ARC8]
Moist Heat or Steam Sterilization
[B040ARC8]
Moist Heat or Steam Sterilization
[B040ARC8]
Moist Heat or Steam Sterilization
[B040ARC8]
Moist Heat or Steam Sterilization
[B040ARC8]
Moist Heat or Steam Sterilization
[B040ARC8]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-13 |
| Device Publish Date | 2024-12-05 |
| B040ARC9 | Aortic Repair Tool Kit - Cusp Calipers |
| B040ARC8 | Aortic Repair Tool Kit - Cusp Calipers |
| B040ARC7 | Aortic Repair Tool Kit - Cusp Calipers |
| B040ARC6 | Aortic Repair Tool Kit - Cusp Calipers |
| B040ARC10 | Aortic Repair Tool Kit - Cusp Calipers |