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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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Counter Sink Drill - 07290109741161

Countersink Drill 5.0X6.0
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109741161 ()
CD 5.0X6.0

  • Fixture/appliance dental drill bit, reusable

iQ®200 - 10837461002475

iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution

  • 10837461002475 ()
800-3704

  • Laboratory instrument/analyser application software IVD

BioPlex - 03610522207992

BPX Syph Total& RPR Mnl&CD SW4.3 v5
BIO-RAD LABORATORIES, INC.
SW4.3 v5.0
In Commercial Distribution

  • 03610522207992 ()

  • 1 Each
12014549

  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

SCHICK - D764B63030001

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

  • D764B63030001 ()


  • Diagnostic-imaging photographic film, self-developing

SCHICK - D764B63060001

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

  • D764B63060001 ()


  • Diagnostic-imaging photographic film, self-developing

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

BioPlex 2200 - 00847865011006

Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
Not in Commercial Distribution

  • 00847865011006 ()

  • 1 Each
6653870D

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010986

BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010986 ()

  • 1 Each
6653270E

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

BioPlex 2200 - 00847865002240

ToRC IgG Assay Protocol File CD, SW 4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002240 ()

  • 1 Each
6651670G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

ARCHITECT - 00380740152147

ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
4J62-18
In Commercial Distribution

  • 00380740152147 ()
04J6218

  • Laboratory instrument/analyser application software IVD
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