ViviGen MIS Delivery System BL-1925-001

GUDID 00889858640244

Delivery System Cannula

LIFENET HEALTH

Bone graft delivery kit

• Primary Device ID: 00889858640244
• NIH Device Record Key: 422f1284-0404-4c54-8154-26df630ce32d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViviGen MIS Delivery System
• Version Model Number: BL-1925-001
• Catalog Number: BL-1925-001
• 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	00889858640244 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-23
• Device Publish Date: 2024-02-15

On-Brand Devices [ViviGen MIS Delivery System]

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