Kiva FRS2100

GUDID 00813478020049

Kiva VCF Treatment System, First Fracture, Right

BENVENUE MEDICAL, INC.

Orthopaedic cement, non-medicated

• Primary Device ID: 00813478020049
• NIH Device Record Key: 44d15e64-bff6-46ca-8724-abbdee5b1199
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kiva
• Version Model Number: FRS2100
• Catalog Number: FRS2100
• Company DUNS: 787732689
• Company Name: BENVENUE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 997-7463
• Email: info@benvenuemedical.com
• Phone: (800) 997-7463
• Email: info@benvenuemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813478020049 [Primary]

FDA Product Code

• LOD: Bone Cement

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Kiva]

• 00813478020438: Verterbral Augmentation Cement
• 00813478020414: Mixing and Injection System
• 00813478020407: Kiva UltraFlex Cement Needle Kit
• 00813478020179: Vertebral Augmentation Cement Kit for Use with Kiva
• 00813478020162: Kiva Introducer Set
• 00813478020155: Kiva Trocar Tip Access Needle, 11GA
• 00813478020148: Kiva Cement Needle Set
• 00813478020131: Kiva Bevel Tip Access Needle, 11GA
• 00813478020124: Kiva Diamond Tip Access Needle, 11GA
• 00813478020117: Bone Drill, 7GA x 17cm
• 00813478020100: Bone Drill, 7GA x 19cm
• 00813478020094: CorePlus Bone Biopsy Needle, 11GA
• 00813478020087: CorePlus Bone Biopsy Needle, 15GA
• 00813478020070: Kiva Pilot, Left
• 00813478020063: Kiva Pilot, Right
• 00813478020056: Kiva VCF Treatment System, First Fracture, Left
• 00813478020049: Kiva VCF Treatment System, First Fracture, Right
• 00813478020032: Kiva VCF Treatment System, Additional Fracture Kit, Left
• 00813478020025: Kiva VCF Treatment System, First Fracture Kit, Left
• 00813478020018: Kiva VCF Treatment System, Additional Fracture Kit, Right
• 00813478020001: Kiva VCF Treatment System, Fisrt Fracture Kit, Right