OmniPore Surgical Implant Cutting Guide

GUDID 00852578008083

InvisiShunt Cutting Guide

MATRIX SURGICAL HOLDINGS, LLC

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00852578008083
• NIH Device Record Key: abacf893-dfe5-4859-ae5a-59e413912011
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniPore Surgical Implant Cutting Guide
• Version Model Number: OP4002
• Company DUNS: 079634199
• Company Name: MATRIX SURGICAL HOLDINGS, 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852578008083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123908

FDA Product Code

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

Sterilization

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

[00852578008083]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-24
• Device Publish Date: 2020-04-16

On-Brand Devices [OmniPore Surgical Implant Cutting Guide ]

• 00855421005987: InvisiShunt Cutting Guide
• 00852578008175: InvisiShunt Cutting Guide
• 00852578008083: InvisiShunt Cutting Guide
• 00852578008052: InvisiShunt Cutting Guide
• 00852578008021: InvisiShunt Cutting Guide