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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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Irix-C Cervical Integrated Fusion System - M697C06601271

Specialty 45 Degree Awl with retractable Sleeve
Xtant Medical Holdings, Inc.
C066-0127
In Commercial Distribution

  • M697C06601270 ()
  • M697C06601271 ()


  • Polymeric spinal interbody fusion cage

Natus® - 00382830056533

Multi-Purpose Valve (High Pressure) with Anti-Siphon Device
NATUS MEDICAL INCORPORATED
NT8500112
In Commercial Distribution


  • Inlet Tube: 1.2mm ID x 2.2mm OD; Outlet Tube: 1.2mm ID x 2.2mm OD
NT8500112

  • Cerebrospinal fluid shunt valve

Natus® - 00382830056526

Multi-Purpose Valve (Medium Pressure) with Anti-Siphon Device
NATUS MEDICAL INCORPORATED
NT8500108
In Commercial Distribution


  • Inlet Tube: 1.2mm ID x 2.2mm OD; Outlet Tube: 1.2mm ID x 2.2mm OD
NT8500108

  • Cerebrospinal fluid shunt valve

Natus® - 00382830056519

Multi-Purpose Valve (Low Pressure) with Anti-Siphon Device
NATUS MEDICAL INCORPORATED
NT8500105
In Commercial Distribution


  • Inlet Tube: 1.2mm ID x 2.2mm OD; Outlet Tube: 1.2mm ID x 2.2mm OD
NT8500105

  • Cerebrospinal fluid shunt valve

Irix-C Cervical Integrated Fusion System - M697C06601281

Specialty 60 Degree Awl with retractable Sleeve
Xtant Medical Holdings, Inc.
C066-0128
In Commercial Distribution

  • M697C06601280 ()
  • M697C06601281 ()


  • Polymeric spinal interbody fusion cage

OsteoMed - 00845694034043

Low Profile Cover Shunt Plate with Groove
OSTEOMED LLC
218-0097
In Commercial Distribution

  • 00845694034043 ()

  • Outer Diameter: 26 Millimeter
218-0097

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

OsteoMed - 00845694002059

ISO Chin Plate with Window, 12mm Step
OSTEOMED LLC
210-0412
In Commercial Distribution

  • 00845694002059 ()

  • Advancement = 12mm
210-0412

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

OsteoMed - 00845694002035

ISO Chin Plate with Window, 8mm Step
OSTEOMED LLC
210-0408
In Commercial Distribution

  • 00845694002035 ()

  • Advancement = 8mm
210-0408

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

OsteoMed - 00845694002042

ISO Chin Plate with Window, 10mm Step
OSTEOMED LLC
210-0410
In Commercial Distribution

  • 00845694002042 ()

  • Advancement = 10mm
210-0410

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

OsteoMed - 00845694002028

ISO Chin Plate with Window, 6mm Step
OSTEOMED LLC
210-0406
In Commercial Distribution

  • 00845694002028 ()

  • Advancement = 6mm
210-0406

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