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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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ARK™ AB-PINACA Cutoff Calibrator is intended for use in calibration of the ARK™ AB-PINACA Assay.
ARK DIAGNOSTICS INC
5055-0002-02
In Commercial Distribution

  • 00812101030370 ()
5055-0002-02

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator
ARK™ AB-PINACA Negative Calibrator is intended for use in calibration of the ARK™ AB-PINACA Assay.
ARK DIAGNOSTICS INC
5055-0002-01
In Commercial Distribution

  • 00812101030363 ()
5055-0002-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator
Castroviejo Corneoscleral Scissors, Medium Blades, 9mm of cutting blade, Right, Serrated Scissor-Action Handle, 105mm total length, Stainless
Diamatrix
S800-R
In Commercial Distribution

  • 00813059016119 ()
S800-R

  • Ocular hook/spatula/manipulator, reusable
Castroviejo Corneoscleral Scissors, Medium Blades, 9mm of cutting blade, Left, Serrated Scissor-Action Handle, 105mm total length, Stainless
Diamatrix
S800-L
In Commercial Distribution

  • 00813059016102 ()
S800-L

  • Ocular hook/spatula/manipulator, reusable
The device is used to evacuate the contents of the uterus. Aspirator is double-valve, and consists of a 60cc syringe barrel, plunger, collar stop, o-ring, and a removable valve liner. Aspirators are clean, sterile, and single use.
WOMANCARE GLOBAL TRADING, INC.
DVS-S10
In Commercial Distribution

  • 00853615006369 ()
  • 10853615006366 ()

  • Outer Diameter: 3.50 Inch
  • Length: 9.00 Inch


  • Abortion suction system collection bottle
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-GSSP
In Commercial Distribution

  • 00812117016825 ()
SECCDX-GSSP

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-A
In Commercial Distribution

  • 00812117016818 ()
SECCDX-A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Structurally encoded implant 17mm long, 4.0mm diameter, sterile packed. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-17-40
In Commercial Distribution

  • 00810005666763 ()

  • Length: 17 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Structurally encoded implant 16mm long, 4.0mm diameter, sterile packed. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-16-40
In Commercial Distribution

  • 00810005666756 ()

  • Length: 16 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Structurally encoded implant 15mm long, 4.0mm diameter, sterile packed. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-15-40
In Commercial Distribution

  • 00810005666749 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 15 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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