Annular Sizer Aortic

GUDID B040ASR19210

Aortic Repair Tool Kit - Annular Sizers

GENESEE BIOMEDICAL, INC.

Heart valve annulus sizer, reusable
Primary Device IDB040ASR19210
NIH Device Record Keyf73e47f2-61f9-444d-9842-c91640439a8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnnular Sizer Aortic
Version Model NumberASR19/21
Company DUNS939872651
Company NameGENESEE BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB040ASR1921 [Package]
Package: [1 Units]
In Commercial Distribution
HIBCCB040ASR19210 [Primary]

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B040ASR19210]

Moist Heat or Steam Sterilization


[B040ASR19210]

Moist Heat or Steam Sterilization


[B040ASR19210]

Moist Heat or Steam Sterilization


[B040ASR19210]

Moist Heat or Steam Sterilization


[B040ASR19210]

Moist Heat or Steam Sterilization


[B040ASR19210]

Moist Heat or Steam Sterilization


[B040ASR19210]

Moist Heat or Steam Sterilization


[B040ASR19210]

Moist Heat or Steam Sterilization


[B040ASR19210]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-13
Device Publish Date2024-12-05

On-Brand Devices [Annular Sizer Aortic]

B040ASR31330Aortic Repair Tool Kit - Annular Sizers
B040ASR2729Aortic Repair Tool Kit - Annular Sizers
B040ASR2325Aortic Repair Tool Kit - Annular Sizers
B040ASR19210Aortic Repair Tool Kit - Annular Sizers

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