Blazer BZK3130

GUDID 00813478020193

Blazer-C Vertebral Augmentation Kit

BENVENUE MEDICAL, INC.

Bone access channel kit

• Primary Device ID: 00813478020193
• NIH Device Record Key: 4410b6dc-1c4d-4ae9-b44c-ff2a2eef10f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blazer
• Version Model Number: BZK3130
• Catalog Number: BZK3130
• Company DUNS: 787732689
• Company Name: BENVENUE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00813478020193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070293

FDA Product Code

• OCJ: Spinal Channeling Instrument, Vertebroplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Blazer]

• 00813478020421: F20 Radiopaque Bone Cement
• 00813478020247: Vertebral Augmentation Cement Kit for Use with Blazer-C
• 00813478020230: Blazer Cement Needle, 11GA
• 00813478020223: Blazer Single Step Bevel Tip Introducer
• 00813478020216: Blazer Single Step Diamond Trocar Tip Introducer
• 00813478020209: Blazer Bone Drill
• 00813478020193: Blazer-C Vertebral Augmentation Kit
• 00813478020186: Blazer-C Vertebral Augmentation System