VALVE 40029 AVALUS AOR MMX U30 US

VALVE 40029 AVALUS AOR MMX U30 US
Avalus™ - 40029

Device Description

A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.

Environmental Conditions

Special Storage Condition, Specify

Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.

Storage Environment Temperature - Degrees Celsius

25.00
5.00

Device Sizes

Valve Size: 29 MM

Valve Size: 29 MM

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DYE

Device Name: Replacement Heart-Valve

Device Class: 3

Physical State: N/A

Definition: Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.3925

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 00643169983229

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A