| Primary Device ID | B040AMGMBD1 |
| NIH Device Record Key | 308ee92a-8cfe-4878-8def-05ca4165f66d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anastomark Coronary Artery Bypass Graft Markers, B |
| Version Model Number | AMGM-BD |
| Company DUNS | 939872651 |
| Company Name | GENESEE BIOMEDICAL, INC. |
| Device Count | 100 |
| 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 | false |
| 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 | B040AMGMBD1 [Primary] |
| HIBCC | B040AMGMBD100 [Unit of Use] |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B040AMGMBD1]
Moist Heat or Steam Sterilization
[B040AMGMBD1]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-01 |
| B040WF26 - WellForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF28 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF30 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF32 - WellsFormTricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF34 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF360 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B0404200260 - NeoForm | 2019-05-30 Annuloplasty Ring |
| B040420028 - NeoForm | 2019-05-30 Annuloplasty Ring |