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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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Tatum Post Guide 20° - 00083208502002

Tatum Post Guide 20° (Gold) -to measure angle of implant placement.
Suncoast Dental, Inc
Post Guide 20°
In Commercial Distribution

  • 00083208502002 ()

  • Angle 20° (Twenty degree)
PG.20°

  • Dental implantation depth/angle gauge, reusable

Tatum Post Guide 10° - 00083208501005

Tatum Post Guide 10° (Blue) -to measure angle of implant placement.
Suncoast Dental, Inc
Post Guide 10°
In Commercial Distribution

  • 00083208501005 ()

  • Angle 10° (Ten degree)
PG.10°

  • Dental implantation depth/angle gauge, reusable

Tatum Post Guide 0° - 00083208500008

Tatum Post Guide 0° -to measure angle of implant placement.
Suncoast Dental, Inc
Post Guide 0°
In Commercial Distribution

  • 00083208500008 ()

  • Angle 0° (Zero degree - Straight)
PG.0°

  • Dental implantation depth/angle gauge, reusable

Detector UA 2GP - 10722355002917

For rapid detection of multiple analytes in human urine.
Immunostics Company, Inc
IDU-2GP
In Commercial Distribution

  • 20722355002914 ()
  • 10722355002917 ()
  • 80722355002916 ()


  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical

Detector UA 10 - 10722355002221

Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Immunostics Company, Inc
IDU-10
In Commercial Distribution

  • 20722355002204 ()
  • 10722355002221 ()
  • 80722355002220 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Detector UA 10SG - 10722355002924

For rapid detection of multiple analytes in human urine.
Immunostics Company, Inc
IDU-10SG
In Commercial Distribution

  • 20722355002921 ()
  • 10722355002924 ()
  • 80722355002923 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Curaplex - 00817617029634

Curaplex Select Defibrillation Electrode, Cardiac Science , Adult 10pr/CASE
BOUND TREE MEDICAL, LLC
T100-CASE
In Commercial Distribution

  • 00817617029641 ()
  • 00817617029634 ()
16382

  • Electrode conductive skin pad, single-use

ACUFEX - 03596010408402

SHOULDER HOLDER
Smith & Nephew, Inc.
7207340
In Commercial Distribution

  • 03596010408402 ()
7207340

  • Arm procedure positioner, reusable

NA - 03596010388926

LATERAL LEG PAD
Smith & Nephew, Inc.
012311
In Commercial Distribution

  • 03596010388926 ()
012311

  • Leg procedure positioner

ACTH [Adrenocorticotropic Hormone] ELISA - 08305900070231

The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use.
BIOMERICA, INC.
7023
Not in Commercial Distribution

  • 08305900070231 ()


  • Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)

HemosIL Plasmin Inhibitor - 08426950031734

HemosIL Plasmin Inhibitor
INSTRUMENTATION LABORATORY COMPANY
00020009200
In Commercial Distribution

  • 08426950031734 ()
00020009200

  • Alpha-2-antiplasmin IVD, kit, enzyme immunoassay (EIA)

N/A - 03596010024527

LEG HOLDER TABLE CLAMP NOT INCLUDED
Smith & Nephew, Inc.
012310
In Commercial Distribution

  • 03596010024527 ()
012310

  • Leg procedure positioner

AccuDiag ™ - 00894175000831

AccuDiag™ Ascaris IgG ELISA For the qualitative detection of immunoglobulin G (IgG) antibodies to the parasitic nematode Ascaris lumbricoides in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD8212-35
In Commercial Distribution

  • 00894175000831 ()

  • 96 Tests
8212-35

  • Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ACCUFLEXPRO+ RECTAL THERMOMETER (RED) - 00057565166498

Accuflex®Pro+ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. This digital thermometer provides quick and accurate readings healthcare professionals can count on. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds for oral readings Washable for easy cleaning Gentle-flex tip for patient comfort Easy to use with large screen for better nighttime visibility Display in Celsius or Fahrenheit Auto shut-off feature Memory recall / display of last 30 readings Individually packaged, includes storage case Anti-Bacterial additive Convenient colour codes – blue for oral and red for rectal
A.M.G. Médicale Inc
016-649
In Commercial Distribution

  • 00057565973461 ()
  • 00057565166498 ()
  • 00057565973478 ()
016-649

  • Intermittent electronic patient thermometer

ACCUFLEXPRO+ ORAL THERMOMETER (BLUE) - 00057565166481

Accuflex®Pro+ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. This digital thermometer provides quick and accurate readings healthcare professionals can count on. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds for oral readings Washable for easy cleaning Gentle-flex tip for patient comfort Easy to use with large screen for better nighttime visibility Display in Celsius or Fahrenheit Auto shut-off feature Memory recall / display of last 30 readings Individually packaged, includes storage case Anti-Bacterial additive Convenient colour codes – blue for oral and red for rectal
A.M.G. Médicale Inc
016-648
In Commercial Distribution

  • 00057565973447 ()
  • 00057565166481 ()
  • 00057565973454 ()
016-648

  • Intermittent electronic patient thermometer

Aquaporin-4 Auto-Antibody (AQP4Ab) - B126KR82000

An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum.
KRONUS, INC.
KR8200
In Commercial Distribution

  • B126KR82000 ()
KR8200

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

KRONUS GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY ELISA ASSAY KIT - B126KR77100

An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum.
KRONUS, INC.
KR7710
In Commercial Distribution

  • B126KR77100 ()
KR7710

  • Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA)

KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT - B126KR67100

An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum.
KRONUS, INC.
KR6710
In Commercial Distribution

  • B126KR67100 ()
KR6710

  • Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, radioimmunoassay

ANTI-THYROGLOBULIN TEST KIT (TgAb) - B126KR62750

A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6275
In Commercial Distribution

  • B126KR62750 ()
KR6275

  • Thyroglobulin antibody IVD, kit, radioimmunoassay

ANTI-THYROGLOBULIN TEST KIT (TgAb) - B126KR62700

A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6270
In Commercial Distribution

  • B126KR62700 ()
KR6270

  • Thyroglobulin antibody IVD, kit, radioimmunoassay

DSG 1 & DSG 3 ELISA TEST - B110RGM7593D0

No Description
Bion Enterprises, Ltd.
RG-M7593-D
Not in Commercial Distribution

  • B110RGM7593D0 ()
RG-M7593-D

  • Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)

X SERIES - 00812394026944

MAIN ASSY, X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
620-2220011-24-66
In Commercial Distribution

  • 00812394026944 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026937

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
602-2220011-24-66
In Commercial Distribution

  • 00812394026937 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026920

MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
620-2221511-24-66
In Commercial Distribution

  • 00812394026920 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026913

X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
602-2221511-24-66
In Commercial Distribution

  • 00812394026913 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026906

MAIN ASSY, X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, SPO2, ETCO2, NIBP, CPR EXPANSION PACK, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
620-2221011-24-66
In Commercial Distribution

  • 00812394026906 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026890

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, SPO2, ETCO2, NIBP, CPR EXPANSION PACK, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
602-2221011-24-66
In Commercial Distribution

  • 00812394026890 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026883

MAIN ASSY, X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, SO. AMERICAN SPANISH, REFURB
Zoll Medical Corporation
620-2220011-23-66
In Commercial Distribution

  • 00812394026883 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026876

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, SO. AMERICAN SPANISH, REFURB
Zoll Medical Corporation
602-2220011-23-66
In Commercial Distribution

  • 00812394026876 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026869

MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, SO. AMERICAN SPANISH, 60HZ, REFURB
Zoll Medical Corporation
620-2221511-23-66
In Commercial Distribution

  • 00812394026869 ()


  • Rechargeable professional automated external defibrillator
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