AccessGUDID - DEVICE: Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal (B040FMPM21)

GUDID

Device Identifier (DI) Information

Brand Name: Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal
Version or Model: FM-PM-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENESEE BIOMEDICAL, INC.

Primary DI Number: B040FMPM21
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 939872651 *Terms of Use

Device Description: Coronary Artery Bypass Graft Markers, Flexible Proximal

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60867	Polymeric coronary bypass marker	A 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].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905067	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4a8711fb-cc49-478c-bcec-6df8d049627b
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: February 01, 2017