| Primary Device ID | B040AMGMD1 |
| NIH Device Record Key | fb16699c-fcc6-4793-9a19-c2ca1004fb4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anastomark Coronary Artery Bypass Graft Markers, S |
| Version Model Number | AMGM-D |
| Company DUNS | 939872651 |
| Company Name | GENESEE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 800 786-4890 |
| infor@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| infor@geneseebiomedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B040AMGMD1 [Primary] |
| HIBCC | B040AMGMD2 [Package] Package: [25 Units] In Commercial Distribution |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-01 |
| B040AMGMSD2 | Coronary Artery Bypass Graft Markers, Stainless Steel, Distal, without Holder |
| B040AMGMPM2 | Coronary Artery Bypass Graft Markers, Stainless Steel, Proximal, Medium |
| B040AMGMD1 | Coronary Artery Bypass Graft Markers, Stainless Steel, Distal, with Holder |