Primary Device ID | B040AMGMSD2 |
NIH Device Record Key | 35774f7f-1278-44e1-8550-d57049671c2c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Anastomark Coronary Artery Bypass Graft Markers, S |
Version Model Number | AMGM-SD |
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 |
info@geneseebiomedical.com | |
Phone | 800 786-4890 |
info@geneseebiomedical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B040AMGMSD1 [Primary] |
HIBCC | B040AMGMSD2 [Package] Contains: B040AMGMSD1 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 |