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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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COOLEY RIB SPREADER ALU, FOR ADULTS, BLADE 21 X 44 MM SPREAD 140 MM
Gimmi GmbH
CD.1163.03
In Commercial Distribution

  • 04049047034544 ()
CD.1163.03

  • Rib spreader, reusable
COOLEY RIB SPREADER; ALU, FOR NEWBORNS, BLADE 12 X 16 MM; SPREAD 70 MM
Gimmi GmbH
CD.1163.01
In Commercial Distribution

  • 04049047034520 ()
CD.1163.01

  • Rib spreader, reusable
Cervical Disc Prep Tray
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207885 ()
CD.1000

  • General internal orthopaedic fixation system implantation kit
Countersink Drill 5.0X6.0
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109741161 ()
CD 5.0X6.0

  • Fixture/appliance dental drill bit, reusable
Countersink Drill 3.75X4.20
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109741154 ()
CD 3.75X4.20

  • Fixture/appliance dental drill bit, reusable
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
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 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
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 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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