WellsFormTricuspid Annuloplasty Band

GUDID B040WF32

Annuloplasty Band

GENESEE BIOMEDICAL, INC.

Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery
Primary Device IDB040WF32
NIH Device Record Keyf4f12be1-224b-4a77-8dc0-f64d29bde6a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellsFormTricuspid Annuloplasty Band
Version Model NumberWF-32
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
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
HIBCCB040WF32 [Package]
Contains: B040WF320
Package: [1 Units]
In Commercial Distribution
HIBCCB040WF320 [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 Date2023-10-10
Device Publish Date2023-10-02

Devices Manufactured by GENESEE BIOMEDICAL, INC.

B040WF26 - WellForm Tricuspid Annuloplasty Band2023-10-10 Annuloplasty Band
B040WF28 - WellsForm Tricuspid Annuloplasty Band2023-10-10 Annuloplasty Band
B040WF30 - WellsForm Tricuspid Annuloplasty Band2023-10-10 Annuloplasty Band
B040WF32 - WellsFormTricuspid Annuloplasty Band2023-10-10Annuloplasty Band
B040WF32 - WellsFormTricuspid Annuloplasty Band2023-10-10 Annuloplasty Band
B040WF34 - WellsForm Tricuspid Annuloplasty Band2023-10-10 Annuloplasty Band
B040WF360 - WellsForm Tricuspid Annuloplasty Band2023-10-10 Annuloplasty Band
B0404200260 - NeoForm2019-05-30 Annuloplasty Ring
B040420028 - NeoForm2019-05-30 Annuloplasty Ring
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