AVATR Minimally Invasive Adult Retractor with atrial and aortic rakes ATR-AR

GUDID B040ATRAR0

Multipurpose retractor for minimally invasive use with atrial and aortic rakes - Thorocotomy, Sternotomy,

GENESEE BIOMEDICAL, INC.

Sternum spreader
Primary Device IDB040ATRAR0
NIH Device Record Key9110cbbb-a576-441f-9f83-a7fe43971315
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVATR Minimally Invasive Adult Retractor with atrial and aortic rakes
Version Model NumberATR-AR
Catalog NumberATR-AR
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com
Phone800-786-4980
Emailcontact@geneseebiomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB040ATRAR0 [Primary]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


[B040ATRAR0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-05
Device Publish Date2024-08-28

Devices Manufactured by GENESEE BIOMEDICAL, INC.

B040ATR1 - AVATR Minimally Invasive Adult Retractor with Interchangeable Blades 2024-09-05 Multipurpose retractor for minimally invasive use - Thorocotomy, Sternotomy,
B040ATRAR0 - AVATR Minimally Invasive Adult Retractor with atrial and aortic rakes2024-09-05Multipurpose retractor for minimally invasive use with atrial and aortic rakes - Thorocotomy, Sternotomy,
B040ATRAR0 - AVATR Minimally Invasive Adult Retractor with atrial and aortic rakes2024-09-05 Multipurpose retractor for minimally invasive use with atrial and aortic rakes - Thorocotomy, Sternotomy,
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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