Home GUDID B040ASR23250 Annular Sizer Aortic
Primary DI B040ASR23250
Brand Annular Sizer Aortic
Company GENESEE BIOMEDICAL, INC.
Model ASR23/25
Device description Aortic Repair Tool Kit - Annular Sizers
Published 2024-12-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DWS Instruments, Surgical, Cardiovascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWS Instruments, Surgical, Cardiovascular Cardiovascular 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B040ASR2325 Package HIBCC 1 In Commercial Distribution B040ASR23250 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Heart valve annulus sizer, reusable A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 939872651 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B040RPS181100 Thoracic Port with Obturator 18x110mm RPS-18110 2026-03-25 B040RPS18500 Thoracic Port with Obturator 18x50mm RPS-1850 2026-03-25 B040RPS18700 Thoracic Port with Obturator 18x70mm RPS-1870 2026-03-25 B040RPS18900 Thoracic Port with Obturator 18x90mm RPS-1890 2026-03-25 B040TF260 TransForm McCarthy Annuloplasty Ring TF-26 2024-12-23 B040TF280 TransForm McCarthy Annuloplasty Ring TF-28 2024-12-23 B040TF300 TransForm McCarthy Annuloplasty Ring TF-30 2024-12-23 B040TF320 TransForm McCarthy Annuloplasty Ring TF-32 2024-12-23 B040TF340 TransForm McCarthy Annuloplasty Ring TF-34 2024-12-23 B040TF380 TransForm McCarthy Annuloplasty Ring TF-38 2024-12-23 B040TF400 TransForm McCarthy Annuloplasty Ring TF-40 2024-12-23 B040TF240 TransForm McCarthy Annuloplasty Ring TF-24 2024-12-23 B040TF26 TransForm McCarthy Annuloplasty Ring TF-26 2024-12-23 B040TF28 TransForm McCarthy Annuloplasty Ring TF-28 2024-12-23 B040TF30 TransForm McCarthy Annuloplasty Ring TF-30 2024-12-23 B040TF32 TransForm McCarthy Annuloplasty Ring TF-32 2024-12-23 B040TF34 TransForm McCarthy Annuloplasty Ring TF-34 2024-12-23 B040TF360 TransForm McCarthy Annuloplasty Ring TF-36 2024-12-23 B040TF38 TransForm McCarthy Annuloplasty Ring TF-38 2024-12-23 B040TF40 TransForm McCarthy Annuloplasty Ring TF-40 2024-12-23
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