InvisiShunt Implant Kit

GUDID 00855113008333

InvisiShunt Implant Kit (OP2001/OP2002)

LONGEVITI NEURO SOLUTIONS LLC

Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00855113008333
• NIH Device Record Key: 26f4e0ea-5a35-4417-9aac-427ae0b1ad32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InvisiShunt Implant Kit
• Version Model Number: OP2000
• 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	00855113008333 [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)