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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Blue Diamond® Gel Toboggan Arm-Leg Shield Liner, a gel pad to offer pressure relief to patients arm ehen toboggan sleds are used to keep arms tucked during surgical procedures.
David Scott Company
BD2245
In Commercial Distribution

  • 15060797551576 ()

  • Width: 11 Inch
  • Length: 17 Inch
  • Depth: .25 Inch
BD2245

  • Operating table patient pressure distribution pad, reusable
The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q240961
In Commercial Distribution

  • 00845533001700 ()
Q240961

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q240241
In Commercial Distribution

  • 00845533001694 ()
Q240241

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q240181
In Commercial Distribution

  • 00845533001687 ()
Q240181

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
The ZEUS ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status, or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients.
ZEUS SCIENTIFIC, INC.
Q3Z17601GB
In Commercial Distribution

  • 00845533000918 ()
Q3Z17601GB

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
Q8Z8651GB
In Commercial Distribution

  • 00845533001205 ()
Q8Z8651GB

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q3Z51021GB
In Commercial Distribution

  • 00845533000642 ()
Q3Z51021GB

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-113
In Commercial Distribution

  • 09348215061821 ()


  • Fluted surgical drill bit, reusable
Rabbit antisera. Ready-To-Use.
Ssi Diagnostica A/S
53827
Not in Commercial Distribution

  • 05713106538272 ()
53827

  • Multiple Salmonella species culture isolate antigen IVD, antibody
Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
52400
In Commercial Distribution

  • 05713106524008 ()
52400

  • Streptococcus pneumoniae culture isolate antigen IVD, antibody
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9040
Not in Commercial Distribution

  • 08806387890409 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9034
Not in Commercial Distribution

  • 08806387890348 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9033
Not in Commercial Distribution

  • 08806387890331 ()


  • Endodontic obturation system
No Description
ACCUTRON, INC.
34668-CUSTOM
Not in Commercial Distribution

  • 90813830020154 ()
34668-CUSTOM

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
26849-FRU
In Commercial Distribution

  • 00813830028287 ()
26849-FRU

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
34087
In Commercial Distribution

  • 00813830022131 ()
34087

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34074
In Commercial Distribution

  • 00813830022018 ()
34074

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34073
In Commercial Distribution

  • 00813830022001 ()
34073

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34072
In Commercial Distribution

  • 00813830021998 ()
34072

  • Nitrous oxide quick-connect coupling, male
No Description
ACCUTRON, INC.
34070
In Commercial Distribution

  • 00813830021974 ()
34070

  • Nitrous oxide quick-connect coupling, male
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