RING SIM SR 800SR34 SEMI-RIGID 34MM

RING SIM SR 800SR34 SEMI
ATS Tri-Ad® - 800SR34

Device Description

A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral or tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.

Environmental Conditions

Special Storage Condition, Specify

Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.

Special Storage Condition, Specify

Store in cool dry place.

Device Sizes

Lumen/Inner Diameter: 34.0 Millimeter

Lumen/Inner Diameter: 34.0 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: KRH

Device Name: Ring, Annuloplasty

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 870.3800

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 00643169301023

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