DEVICE: Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal (B040FMPM31)

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Device Identifier (DI) Information

Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal
FM-PM-3

GENESEE BIOMEDICAL, INC.
B040FMPM31
HIBCC
3
Coronary Artery Bypass Graft Markers, Flexible Proximal
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polymeric coronary bypass marker A sterile device intended to be implanted during coronary artery bypass graft surgery, at the point of the arterial anastomosis, to provide clear postsurgical radiographic verification of the arterial anastomosis. It is in the form of a synthetic polymer ring (e.g., silicone) impregnated with a metal [e.g., tungsten (W)] to aid visualization, and is compatible with the imaging system with which it is intended to be visualized/exposed [e.g., magnetic resonance imaging (MRI), fluoroscopy]. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
February 01, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B040FMPM32 3 B040FMPM31 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: B040FMPM3 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800 786-4890
info@geneseebiomedical.com
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