TOOL 7620H HANDLE DURAN ANCORE 14L
Duran AnCore® - 7620H
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
- Length: 8.5 Inch
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: DTI
Device Name: Sizer, Heart-Valve, Prosthesis
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: N
Target Area: N/A
Regulation Number: 870.3945
Third Party Flag: N
Medical Specialty: CV
Device Identifiers
Device Id: 00885074426815
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
