ViviGen MIS Delivery System BL-1900-001

GUDID 00889858628419

Delivery System Cannula

LIFENET HEALTH

Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit

• Primary Device ID: 00889858628419
• NIH Device Record Key: 29b9ce50-69d0-4553-819c-38bdfb47f5fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViviGen MIS Delivery System
• Version Model Number: BL-1900-001
• Catalog Number: BL-1900-001
• Company DUNS: 121828156
• Company Name: LIFENET HEALTH
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889858628419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201338

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-09-06
• Device Publish Date: 2021-05-19

On-Brand Devices [ViviGen MIS Delivery System]

• 00889858628402: Delivery System Cannula
• 00889858625203: Delivery System Dispenser
• 00889858628419: Delivery System Cannula
• 00889858640244: Delivery System Cannula