Anastomark Coronary Artery Bypass Graft Markers, F

GUDID B040FMPM32

Coronary Artery Bypass Graft Markers, Flexible Proximal

GENESEE BIOMEDICAL, INC.

Polymeric coronary bypass marker
Primary Device IDB040FMPM32
NIH Device Record Key12e85959-f03c-4324-8a49-878643f45294
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnastomark Coronary Artery Bypass Graft Markers, F
Version Model NumberFM-PM-3
Company DUNS939872651
Company NameGENESEE BIOMEDICAL, INC.
Device Count3
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB040FMPM3 [Unit of Use]
HIBCCB040FMPM31 [Primary]
HIBCCB040FMPM32 [Package]
Contains: B040FMPM31
Package: [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-01

On-Brand Devices [Anastomark Coronary Artery Bypass Graft Markers, F]

B040FMPM32Coronary Artery Bypass Graft Markers, Flexible Proximal
B040FMPM22Coronary Artery Bypass Graft Markers, Flexible Proximal
B040FMPM12Coronary Artery Bypass Graft Markers, Flexible Proximal

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