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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-A INTEGRATED SPACER ASSY, 38 X 28 X 8°, 11mm, CE MARKED
Xtant Medical Holdings, Inc.
X080-382811-08X
In Commercial Distribution

  • M697X08038281108X1 ()

  • Width: 38 Millimeter
  • Angle: 8 degree
  • Length: 28 Millimeter
  • Height: 11 Millimeter


  • Polymeric spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 8°, 11mm, PC
Xtant Medical Holdings, Inc.
X080-382811-08TPC
Not in Commercial Distribution

  • M697X08038281108TPC1 ()

  • Height: 11 Millimeter
  • Width: 38 Millimeter
  • Length: 28 Millimeter
  • Angle: 8 degree


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 8°, 11mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-382811-08PC-STRX
In Commercial Distribution

  • M697X08038281108PCSTRX1 ()

  • Height: 11 Millimeter
  • Angle: 8 degree
  • Length: 28 Millimeter
  • Width: 38 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 8°, 11mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-382811-08PC-STR
In Commercial Distribution

  • M697X08038281108PCSTR1 ()

  • Length: 28 Millimeter
  • Height: 11 Millimeter
  • Angle: 8 degree
  • Width: 38 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
BiTech Bipolar Scissor 28 cm fine delicate blade, curved, grey, round plug
Günter Bissinger Medizintechnik GmbH
85728130
In Commercial Distribution

  • 04250418724555 ()
85728130

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Syva® Emit® II Plus Ethyl Alcohol Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445446
In Commercial Distribution

  • 00842768014413 ()
9K039UL

  • Ethanol (ETOH) IVD, kit, spectrophotometry
Syva® Emit® II Plus Cocaine Metabolite Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445438
In Commercial Distribution

  • 00842768014390 ()
9H039UL

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
SensiLance, Button Activated Safety Lancets, Sterile, 28 Gauge Needle, 1.8mm Depth Setting
Dynarex Corporation
7125
In Commercial Distribution

  • 00616784712512 ()
  • 00616784712529 ()
  • 00616784712536 ()


  • Blood lancet, single-use
4.0 Cancellous Bone Shaft Screw, hex, _x000D_St.Steel, L 28/14 mm _x000D_
mahe medical gmbh
001-0006-028
In Commercial Distribution

  • 04050659167568 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
MCD Mini DTS Screw 2.5/3.0 x 28 mm self-drilling cannulated grey
MONDEAL Medical Systems GmbH
26-50828
Not in Commercial Distribution

  • 04050435118722 ()
26-50828

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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