InvisiShunt Cutting Guide

GUDID 00855113008357

InvisiShunt Cutting Guide (OP2002)

LONGEVITI NEURO SOLUTIONS LLC

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00855113008357
• NIH Device Record Key: 9833f7bd-6f63-4193-8fa1-4226c3ad7865
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InvisiShunt Cutting Guide
• Version Model Number: OP2002
• 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: false
• 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	00855113008357 [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 Cutting Guide]

• 00855113008432: InvisiShunt Cutting Guide (OP5002)
• 00855113008401: InvisiShunt Cutting Guide (OP4002)
• 00855113008388: InvisiShunt Implant Cutting Guide (OP3002)
• 00855113008357: InvisiShunt Cutting Guide (OP2002)
• 00855113008326: OP1002 InvisiShunt Cutting Guide