TruForm Annuloplasty Ring

GUDID B040TRH42

Annuloplasty Ri

GENESEE BIOMEDICAL, INC.

Mitral/tricuspid annuloplasty ring, open-surgery
Primary Device IDB040TRH42
NIH Device Record Keyb8952c6a-56b5-4e00-a1cd-2a3ec73cc81d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruForm Annuloplasty Ring
Version Model NumberTRH-42
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
HIBCCB040TRH42 [Package]
Contains: B040TRH420
Package: [1 Units]
In Commercial Distribution
HIBCCB040TRH420 [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 Date2024-12-12
Device Publish Date2024-12-04

On-Brand Devices [TruForm Annuloplasty Ring]

B040TRH42Annuloplasty Ri
B040TRH40Annuloplasty Ri
B040TRH38Annuloplasty Ri
B040TRH36Annuloplasty Ri
B040TRH34Annuloplasty Ri
B040TRH32Annuloplasty Ri
B040TRH30Annuloplasty Ring
B040TRH28Annuloplasty Ring
B040TFH26Annuloplasty Ring
B040TRH24Annuloplasty Ring

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