NeoForm

GUDID B040420028

Annuloplasty Ring

GENESEE BIOMEDICAL, INC.

Mitral/tricuspid annuloplasty ring
Primary Device IDB040420028
NIH Device Record Keyc4aa09b6-99cb-4c25-9c40-8e81f421b4b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoForm
Version Model Number4200-28
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 Latexfalse
RX Perscriptionfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB040420028 [Package]
Contains: B0404200280
Package: [1 Units]
In Commercial Distribution
HIBCCB0404200280 [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 Date2019-05-30
Device Publish Date2019-05-22

On-Brand Devices [NeoForm]

B040420032Annuloplasty Ring
B040420030Annuloplasty Ring
B040420028Annuloplasty Ring
B0404200260Annuloplasty Ring

Trademark Results [NeoForm]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEOFORM
NEOFORM
87720950 5814328 Live/Registered
Genesee BioMedical, Inc.
2017-12-14
NEOFORM
NEOFORM
78974713 3413537 Dead/Cancelled
MENTOR WORLDWIDE LLC
2006-09-14
NEOFORM
NEOFORM
78848110 3272091 Dead/Cancelled
DENTSPLY INTERNATIONAL INC.
2006-03-28
NEOFORM
NEOFORM
77010092 3294538 Live/Registered
Trico Products Corporation
2006-09-28
NEOFORM
NEOFORM
75476258 2517787 Live/Registered
DEXTER MAGNETIC TECHNOLOGIES, INC.
1998-04-29
NEOFORM
NEOFORM
75112781 not registered Dead/Abandoned
Flexor, Inc.
1996-06-03
NEOFORM
NEOFORM
74336871 1870451 Dead/Cancelled
ROYCE MEDICAL COMPANY
1992-12-04

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