DEVICE: Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal (B040FMPM11)

Device Identifier (DI) Information

Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal
FM-PM-1
In Commercial Distribution

GENESEE BIOMEDICAL, INC.
B040FMPM11
HIBCC

1
939872651 *Terms of Use
Coronary Artery Bypass Graft Markers, Flexible Proximal
CLOSE

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.
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

e70a86c4-969e-4136-bc25-20cad5b6dfc4
March 29, 2018
2
February 01, 2017
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B040FMPM12 25 B040FMPM11 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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