OmniPore Customized Surgical Implant Cutting Guide

GUDID 00852578008151

Customized Implant Cutting Guide

MATRIX SURGICAL HOLDINGS, LLC

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00852578008151
• NIH Device Record Key: c9ff03fc-ea48-4633-9d53-73684248ab90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniPore Customized Surgical Implant Cutting Guide
• Version Model Number: OP89027
• 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	00852578008151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133046

FDA Product Code

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

Sterilization

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

[00852578008151]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-05
• Device Publish Date: 2020-04-27

Devices Manufactured by MATRIX SURGICAL HOLDINGS, LLC

• 00855421005079 - OmniPore Surgical Implant: 2024-03-05 3S™ Sheet
• 00852578008199 - OmniPore Surgical Implant: 2023-12-28 16mm Orbital EME Sphere
• 00852578008205 - OmniPore Surgical Implant: 2023-12-28 18mm Orbital EME Sphere
• 00852578008212 - OmniPore Surgical Implant: 2023-12-28 20mm Orbital EME Sphere
• 00852578008229 - OmniPore Surgical Implant: 2023-12-28 22mm Orbital EME Sphere
• 00852578008236 - OmniPore Surgical Implant: 2023-08-15 Single Piece Ear Implant - Small - Right
• 00852578008243 - OmniPore Surgical Implant: 2023-08-15 Single Piece Ear Implant - Small - Left
• 00852578008250 - OmniPore Surgical Implant: 2023-08-15 Single Piece Ear Implant - Medium - Right