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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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LEVEL ONE NEURO, STERILE - 00888118034830

MESH, STANDARD, LOW PROFILE, NEURO SCREW, CP TITANIUM
KLS-Martin L.P.
25-003-11-71
In Commercial Distribution

  • 00888118034830 ()

  • 84 X 53 MM, T=0.3 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

LEVEL ONE NEURO, STERILE - 00888118034816

MESH, STANDARD, NEURO SCREW, CP TITANIUM
KLS-Martin L.P.
25-003-10-71
In Commercial Distribution

  • 00888118034816 ()

  • 84 X 53 MM, T=0.3 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Esteem Intraoperative System Analyzer - 00812282020610

Model 3001 ISA, Sterile Cable Pack, Sensor/Driver-to-PID
Envoy Medical Corporation
3200
In Commercial Distribution

  • 00812282020610 ()
903200-002

  • Fully-implantable middle ear implant system

Esteem® Intraoperative System Analyzer - 00812282020443

Intraoperative System Analyzer (ISA), Sterile Cable, PID to Driver
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020443 ()
803045-002

  • Fully-implantable middle ear implant system

Esteem® Driver - 00812282020030

Driver Model 7510, IS-1 Connector
Envoy Medical Corporation
7510
In Commercial Distribution

  • 00812282020030 ()
907510-001

  • Fully-implantable middle ear implant system

Esteem® Driver - 00812282020023

Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020023 ()
907504-003

  • Fully-implantable middle ear implant system

Esteem® Driver - 00812282020016

Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020016 ()
907504-001

  • Fully-implantable middle ear implant system

NA - 07613327382563

1.5/1.7MM DYNAMIC MESH-STD-MEDIUM-S
Stryker Leibinger GmbH & Co. KG
56-90614S
In Commercial Distribution

  • 07613327382563 ()

  • Length: 90.0 Millimeter
  • Width: 90.0 Millimeter
  • Thickness: 0.6 Millimeter
56-90614S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 07613327382556

1.2MM DYNAMIC MESH-STD-LARGE-S
Stryker Leibinger GmbH & Co. KG
56-90626S
In Commercial Distribution

  • 07613327382556 ()

  • Length: 120.0 Millimeter
  • Width: 120.0 Millimeter
  • Thickness: 0.6 Millimeter
56-90626S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 07613327382549

1.5/1.7MM DYNAMIC MESH-STD-LARGE-S
Stryker Leibinger GmbH & Co. KG
56-90616S
In Commercial Distribution

  • 07613327382549 ()

  • Thickness: 0.6 Millimeter
  • Length: 120.0 Millimeter
  • Width: 120.0 Millimeter
56-90616S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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