TransForm McCarthy Annuloplasty Ring

GUDID B040TF28

Mitral/tricuspid annuloplasty ring, open-surgery

Primary Device ID	B040TF28
NIH Device Record Key	46b93304-ed74-412a-aae5-fd75450186dc
Commercial Distribution Status	In Commercial Distribution
Brand Name	TransForm McCarthy Annuloplasty Ring
Version Model Number	TF-28
Company DUNS	939872651
Company Name	GENESEE BIOMEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B040TF28 [Package] Contains: B040TF280 Package: [1 Units] In Commercial Distribution
HIBCC	B040TF280 [Primary]

KRH	Ring, Annuloplasty

Steralize Prior To Use	false
Device Is Sterile	true