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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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ARCHITECT - 00380740152130

ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
8G98-18
In Commercial Distribution

  • 00380740152130 ()
08G9818

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 00847865012607

EBV IgG Assay Protocol File CD, SW4.1_v1, US
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865012607 ()

  • 1 Each
6651270D

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

SCHICK - D764B63060001

USBCAM4 KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
SIRONA DENTAL, INC.
B6306000
In Commercial Distribution

  • D764B63060001 ()


  • Diagnostic-imaging photographic film, self-developing

SCHICK - D764B63030001

USBCAM KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
SIRONA DENTAL, INC.
B6303000
In Commercial Distribution

  • D764B63030001 ()


  • Diagnostic-imaging photographic film, self-developing

BOSS Instruments - 00888515228634

Sickle Knife, 7.5mm cd bld, 6 1/2"
BOSS INSTRUMENTS, LTD., INC.
90-3301
In Commercial Distribution

  • 00888515228634 ()
90-3301

  • Ear knife

DETECTABUSE - 00810042684447

STABILITY/QC CONTROL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008793
In Commercial Distribution

  • 00810042684447 ()
18008793

  • Multiple drugs of abuse IVD, control

DETECTABUSE - 00810042684430

STABILITY/QC CONTROL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008792
In Commercial Distribution

  • 00810042684430 ()
18008792

  • Multiple drugs of abuse IVD, control

Persona Knee System - 00889024472068

No Description
Zimmer, Inc.
82-0156-858-29
In Commercial Distribution

  • 00889024472068 ()

  • Height: 14 Millimeter
  • Femur: 3-9, Tibia: C-D
82-0156-858-29

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472051

No Description
Zimmer, Inc.
82-0156-858-28
In Commercial Distribution

  • 00889024472051 ()

  • Femur: 3-9, Tibia: C-D
  • Height: 13 Millimeter
82-0156-858-28

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472044

No Description
Zimmer, Inc.
82-0156-858-27
In Commercial Distribution

  • 00889024472044 ()

  • Height: 12 Millimeter
  • Femur: 3-9, Tibia: C-D
82-0156-858-27

  • Knee tibia prosthesis trial, reusable
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