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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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No Description
KEOS
23L x 8W x 11H Straight
In Commercial Distribution

  • B084KPS12308110 ()
KPS1-230811

  • Polymeric spinal interbody fusion cage
No Description
KEOS
23L x 8W x 10H Straight
In Commercial Distribution

  • B084KPS12308100 ()
KPS1-230810

  • Polymeric spinal interbody fusion cage
No Description
KEOS
23L x 8W x 9H Straight
In Commercial Distribution

  • B084KPS12308090 ()
KPS1-230809

  • Polymeric spinal interbody fusion cage
No Description
KEOS
23L x 8W x 8H Straight
In Commercial Distribution

  • B084KPS12308080 ()
KPS1-230808

  • Polymeric spinal interbody fusion cage
No Description
KEOS
23L x 8W x 7H Straight
In Commercial Distribution

  • B084KPS12308070 ()
KPS1-230807

  • Polymeric spinal interbody fusion cage
No Description
KEOS
23L x 8W x 6H Straight
In Commercial Distribution

  • B084KPS12308060 ()
KPS1-230806

  • Polymeric spinal interbody fusion cage
The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. The Chemistry calibrator is a human based serum. The concentration of the calibrator components have been adjusted to ensure optimal calibration of the CDS methods on specified analyzers. The product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains additives to provide the defined assay values. The concentrations of the calibrator components are lot-specific.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
10 x 5mL, 1 x 50mL
In Commercial Distribution

  • 00812137012111 ()
  • 00812137012401 ()
502-151

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only. C-reactive protein (CRP) is an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. As such, CRP is considered to be one of the most sensitive indicators of inflammation.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 50mL, R2 x 50mL
In Commercial Distribution

  • 00812137012098 ()
  • 00812137012364 ()
501-435

  • C-reactive protein (CRP) IVD, reagent
Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 17.5cm x 8.0cm x 1.7cm
In Commercial Distribution

  • M724CCB7T911 ()
CCB7-T-91

  • Silicone-block tissue reconstructive material
Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 16.5cm x 7.2cm x 1.6cm
In Commercial Distribution

  • M724CCB7T811 ()
CCB7-T-81

  • Silicone-block tissue reconstructive material
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