InvisiShunt Implant Kit

GUDID 00855113008302

InvisiShunt Implant Kit (OP1001/OP1002)

LONGEVITI NEURO SOLUTIONS LLC

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00855113008302
• NIH Device Record Key: 6ff189b9-6375-4610-a606-ed31d2fae71f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InvisiShunt Implant Kit
• Version Model Number: OP1000
• Company DUNS: 070659539
• Company Name: LONGEVITI NEURO SOLUTIONS LLC
• 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: true
• 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	00855113008302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211514

FDA Product Code

• KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-03-27

On-Brand Devices [InvisiShunt Implant Kit]

• 00855113008418: InvisiShunt Implant Kit (OP5001/OP5002)
• 00855113008395: InvisiShunt Implant Kit (OP4001/OP4002)
• 00855113008364: InvisiShunt Implant Kit (OP3001/OP3002)
• 00855113008333: InvisiShunt Implant Kit (OP2001/OP2002)
• 00855113008302: InvisiShunt Implant Kit (OP1001/OP1002)