OmniPore Customized Surgical Implant

GUDID 00855421005413

Customized Facial Implant

MATRIX SURGICAL HOLDINGS, LLC

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00855421005413
• NIH Device Record Key: c64d1c28-1c51-44e2-a1e0-655612df9ffe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniPore Customized Surgical Implant
• Version Model Number: OP89021
• 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	00855421005413 [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

[00855421005413]

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

On-Brand Devices [OmniPore Customized Surgical Implant ]

• 00855421005420: Contralateral Customized Facial Implant
• 00855421005413: Customized Facial Implant
• 00855421005406: Customized Cranial Implant