TransForm McCarthy Annuloplasty Ring

GUDID B040TF30

Annuloplasty Ring

GENESEE BIOMEDICAL, INC.

Mitral/tricuspid annuloplasty ring, open-surgery
Primary Device IDB040TF30
NIH Device Record Key8480807d-ab3f-4bc7-a117-bec5d3b6b596
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransForm McCarthy Annuloplasty Ring
Version Model NumberTF-30
Company DUNS939872651
Company NameGENESEE BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB040TF30 [Package]
Contains: B040TF300
Package: [1 Units]
In Commercial Distribution
HIBCCB040TF300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRHRing, Annuloplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-31
Device Publish Date2024-12-23

On-Brand Devices [TransForm McCarthy Annuloplasty Ring]

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B040TF32Annuloplasty Ring
B040TF30Annuloplasty Ring
B040TF28Annuloplasty Ring
B040TF26Annuloplasty Ring
B040TF240Annuloplasty Ring

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