WellForm Tricuspid Annuloplasty Band

GUDID B040WF26

Annuloplasty Band

GENESEE BIOMEDICAL, INC.

Mitral/tricuspid annuloplasty ring, open-surgery
Primary Device IDB040WF26
NIH Device Record Key0c8d6a8d-78c5-4fda-a77a-9ee477094822
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellForm Tricuspid Annuloplasty Band
Version Model NumberWF-26
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
HIBCCB040WF26 [Package]
Contains: B040WF260
Package: [1 Units]
In Commercial Distribution
HIBCCB040WF260 [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.

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B040CSR1 - Child Curved Sternal Retractor with Blades Only2024-09-05 Child Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 15 to 45kg
B040CSRAR0 - Child Curved Sternal Retractor with Blades Only2024-09-05 Child Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 15 to 45 kg
B040MMX1 - MINIMAX Minimally Invasive Retractor 2024-09-05 Multipurpose retractor for minimally invasive thoracic use
B040MMX1R0 - MINIMAX Minimally Invasive Retractor 2024-09-05 Multipurpose retractor for minimally invasive thoracic use including radiolucent blades
B040NSR1 - Neonatal Curved Sternal Retractor with Blades Only2024-09-05 Neonatal Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 0.5 to 5kg
B040NSRAR0 - Neonatal Curved Sternal Retractor with Blades Only2024-09-05 Neonatal Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 0.5 to 5kg

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