BAND 638BL38 CG FUTURE 10L

BAND 638BL38 CG FUTURE 10L
CG FUTURE® - 638BL38

Device Description

A circular band intended to be implanted in the heart to support a mitral valve annulus for the reconstruction and/or remodelling of an insufficient and/or stenotic mitral valve. 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

Keep Away From Heat

Special Storage Condition, Specify

Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.

Special Storage Condition, Specify

Keep Dry

Device Sizes

Lumen/Inner Diameter: 38.0 Millimeter

Lumen/Inner Diameter: 38.0 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: 00613994521088

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