HANDLE 7615XL ANNULOPLASTY XL 26L CE

HANDLE 7615XL ANNULOPLASTY XL 26L CE
NA - 7615XL

A hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. The device is typically made of metal and/or plastic (e.g., polysulphone) and is straight and/or curved, rigid and/or flexible in design; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device.

No Data Available

• Length: 373.0 Millimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: DTJ

Device Name: Holder, 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: 870.3935

Third Party Flag: N

Medical Specialty: CV

Device Id: 00763000318444

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