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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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Lumbar IBFD - B084KPS12310060

No Description
KEOS
23L x 10W x 6H Straight
In Commercial Distribution

  • B084KPS12310060 ()
KPS1-231006

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308160

No Description
KEOS
23L x 8W x 16H Straight
In Commercial Distribution

  • B084KPS12308160 ()
KPS1-230816

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308150

No Description
KEOS
23L x 8W x 15H Straight
In Commercial Distribution

  • B084KPS12308150 ()
KPS1-230815

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308140

No Description
KEOS
23L x 8W x 14H Straight
In Commercial Distribution

  • B084KPS12308140 ()
KPS1-230814

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308130

No Description
KEOS
23L x 8W x 13H Straight
In Commercial Distribution

  • B084KPS12308130 ()
KPS1-230813

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308120

No Description
KEOS
23L x 8W x 12H Straight
In Commercial Distribution

  • B084KPS12308120 ()
KPS1-230812

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308110

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

  • B084KPS12308110 ()
KPS1-230811

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308100

No Description
KEOS
23L x 8W x 10H Straight
In Commercial Distribution

  • B084KPS12308100 ()
KPS1-230810

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308090

No Description
KEOS
23L x 8W x 9H Straight
In Commercial Distribution

  • B084KPS12308090 ()
KPS1-230809

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308080

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

  • B084KPS12308080 ()
KPS1-230808

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308070

No Description
KEOS
23L x 8W x 7H Straight
In Commercial Distribution

  • B084KPS12308070 ()
KPS1-230807

  • Polymeric spinal interbody fusion cage

Lumbar IBFD - B084KPS12308060

No Description
KEOS
23L x 8W x 6H Straight
In Commercial Distribution

  • B084KPS12308060 ()
KPS1-230806

  • Polymeric spinal interbody fusion cage

DENTAL ATTACHMENTS - D821098SSSUS0

SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis.
RHEIN 83 SRL
OT STRATEGY x DUPLICATION x USA
Not in Commercial Distribution

  • D821098SSSUS0 ()
098SSSUS

  • Dental implant suprastructure, permanent, preformed

Chemistry Calibrator Set - 00812137012111

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

CRP Reagent Set - 00812137012098

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

Cimeosil® Scar Management, Gel Sheet - M724GS10121

Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
10" x 12" (25.4cm x 30.5cm)
In Commercial Distribution

  • M724GS10121 ()
GS-10-12

  • Scar-management dressing, reusable

Cimeosil® Scar Management, Gel Sheet - M724GS04051

Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
4" x 5" (10.2cm x 12.7cm)
In Commercial Distribution

  • M724GS04051 ()
GS-04-05

  • Scar-management dressing, reusable

Calf Implant, Textured SDM - M724CCB7T911

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, Textured SDM - M724CCB7T811

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

Calf Implant, Textured SDM - M724CCB7T711

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 16.0cm x 6.3cm x 1.5cm
In Commercial Distribution

  • M724CCB7T711 ()
CCB7-T-71

  • Silicone-block tissue reconstructive material

Calf Implant, Textured SDM - M724CCB7T611

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 18.6cm x 9.4cm x 2.2cm
In Commercial Distribution

  • M724CCB7T611 ()
CCB7-T-61

  • Silicone-block tissue reconstructive material

Calf Implant, Textured SDM - M724CCB7T511

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 16.0cm x 9.0cm x 2.0cm
In Commercial Distribution

  • M724CCB7T511 ()
CCB7-T-51

  • Silicone-block tissue reconstructive material

Calf Implant, Textured SDM - M724CCB7T411

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 14.5cm x 7.5cm x 1.7cm
In Commercial Distribution

  • M724CCB7T411 ()
CCB7-T-41

  • Silicone-block tissue reconstructive material

Calf Implant, Textured SDM - M724CCB7T311

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 14.3cm x 6.5cm x 1.6cm
In Commercial Distribution

  • M724CCB7T311 ()
CCB7-T-31

  • Silicone-block tissue reconstructive material

Calf Implant, Textured SDM - M724CCB7T211

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 12.7cm x 6.0cm x 1.5cm
In Commercial Distribution

  • M724CCB7T211 ()
CCB7-T-21

  • Silicone-block tissue reconstructive material

Calf Implant, Smooth SDM - M724CCB7S911

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 17.5cm x 8.0cm x 1.7cm
In Commercial Distribution

  • M724CCB7S911 ()
CCB7-S-91

  • Silicone-block tissue reconstructive material

Calf Implant, Smooth SDM - M724CCB7S811

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 16.5cm x 7.2cm x 1.6cm
In Commercial Distribution

  • M724CCB7S811 ()
CCB7-S-81

  • Silicone-block tissue reconstructive material

Calf Implant, Smooth SDM - M724CCB7S711

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 16.0cm x 6.3cm x 1.5cm
In Commercial Distribution

  • M724CCB7S711 ()
CCB7-S-71

  • Silicone-block tissue reconstructive material

ContourFlex™ Calf Implant, Smooth (Aiache Style) - M724CCB7S611

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 18.6cm x 9.4cm x 2.2cm
In Commercial Distribution

  • M724CCB7S611 ()
CCB7-S-61

  • Silicone-block tissue reconstructive material

Calf Implant, Smooth SDM - M724CCB7S511

Calf Implant
IMPLANTECH ASSOCIATES, INC.
Size: 16.0cm x 9.0cm x 2.0cm
In Commercial Distribution

  • M724CCB7S511 ()
CCB7-S-51

  • Silicone-block tissue reconstructive material
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