OmniPore Surgical Implant

GUDID 00855421005598

Design Y™ Malar - Medium - Left

MATRIX SURGICAL HOLDINGS, LLC

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00855421005598
• NIH Device Record Key: a23399e5-fc0c-4e69-81b1-9ca97227cf37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniPore Surgical Implant
• Version Model Number: OP9516
• 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	00855421005598 [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

[00855421005598]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-04-23

On-Brand Devices [OmniPore Surgical Implant ]

• 90852578008000: InvisiShunt Kit (OP1001/OP1002)
• 00855421005970: OmniPore Surgical Implant
• 00852578008182: InvisiShunt Kit (OP5001/OP5002)
• 00852578008168: InvisiShunt Implant
• 00852578008090: InvisiShunt Kit (OP4001/OP4002)
• 00852578008076: OmniPore Surgical Implant
• 00852578008069: InvisiShunt Implant Kit
• 00852578008045: InvisiShunt Implant
• 00852578008038: InvisiShunt Kit (OP2001/OP2002)
• 00852578008014: InvisiShunt Implant
• 00855421005963: Burr Hole Cover
• 00855421005956: Burr Hole Cover
• 00855421005826: Bendblock Implant
• 00855421005352: Block
• 00855421005345: Block
• 00855421005338: Block
• 00855421005321: Block
• 00855421005314: Block
• 00855421005307: Block
• 00855421005161: Orbital Sphere
• 00855421005154: Orbital Sphere
• 00855421005147: Orbital Sphere
• 00855421005130: Orbital Sphere
• 00855421005123: Orbital Sphere
• 00855421005048: Sheet
• 00855421005031: Sheet
• 00855421005024: Ultra Thin Sheet
• 00855421005000: Ultra Thin Sheet
• 00855421005840: Design Y™ Inferior Orbital Rim - Right
• 00855421005833: Design Y™ Inferior Orbital Rim - Left
• 00855421005574: Design Y™ Malar - Small -Left
• 00855421005567: Design Y™ Malar - Small - Right
• 00855421005949: CHANNEL Sheet
• 00855421005895: Large Paranasal - Right
• 00855421005888: Large Paranasal - Left
• 00855421005871: Petite Paranasal - Right
• 00855421005864: Petite Paranasal - Left
• 00855421005857: Extended Orbital Rim - Left
• 00855421005819: BENDBLOCK™ TF2 Large - Right
• 00855421005802: BENDBLOCK™ TF2 Large - Left
• 00855421005796: BENDBLOCK™ TF2 Medium - Right
• 00855421005789: BENDBLOCK™ TF2 Medium - Left
• 00855421005772: BENDBLOCK™ TF2 Small - Right
• 00855421005765: BENDBLOCK™ TF2 Small - Left
• 00855421005758: BENDBLOCK™ Cranial Grid Implant
• 00855421005741: Cranial Hemisphere - Left
• 00855421005734: Cranial Hemisphere - Right
• 00855421005635: Pterional Implant - Left
• 00855421005628: Pterional Implant - Right
• 00855421005611: Design Y™ Malar - Large - Left