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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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16mm Orbital EME Sphere
MATRIX SURGICAL HOLDINGS, LLC
OP6300
In Commercial Distribution

  • 00852578008199 ()


  • Polyethylene craniofacial tissue reconstructive material
InvisiShunt Kit (OP5001/OP5002)
MATRIX SURGICAL HOLDINGS, LLC
OP5000
In Commercial Distribution

  • 00852578008182 ()


  • Polyethylene craniofacial tissue reconstructive material
InvisiShunt Cutting Guide
MATRIX SURGICAL HOLDINGS, LLC
OP5002
In Commercial Distribution

  • 00852578008175 ()


  • Polyethylene craniofacial tissue reconstructive material
InvisiShunt Implant
MATRIX SURGICAL HOLDINGS, LLC
OP5001
In Commercial Distribution

  • 00852578008168 ()


  • Polyethylene craniofacial tissue reconstructive material
Customized Implant Cutting Guide
MATRIX SURGICAL HOLDINGS, LLC
OP89027
In Commercial Distribution

  • 00852578008151 ()


  • Polyethylene craniofacial tissue reconstructive material
DUROMAX® ZB - FL MW
MATRIX SURGICAL HOLDINGS, LLC
OP9662
In Commercial Distribution

  • 00852578008144 ()


  • Polyethylene craniofacial tissue reconstructive material
DUROMAX® Orbital Implant - Large - 1.5mm
MATRIX SURGICAL HOLDINGS, LLC
OP9561
In Commercial Distribution

  • 00852578008137 ()


  • Polyethylene craniofacial tissue reconstructive material
DUROMAX® Orbital Implant - Large - 1.0mm
MATRIX SURGICAL HOLDINGS, LLC
OP9560
In Commercial Distribution

  • 00852578008120 ()


  • Polyethylene craniofacial tissue reconstructive material
DUROMAX® Orbital Implant - Small - 1.5mm
MATRIX SURGICAL HOLDINGS, LLC
OP9551
In Commercial Distribution

  • 00852578008113 ()


  • Polyethylene craniofacial tissue reconstructive material
DUROMAX® Orbital Implant - Small - 1.0mm
MATRIX SURGICAL HOLDINGS, LLC
OP9550
In Commercial Distribution

  • 00852578008106 ()


  • Polyethylene craniofacial tissue reconstructive material
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