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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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PTS® - 04046964311055

PTS405 PTS BALLOON 40MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613707
In Commercial Distribution

  • 04046964311055 ()
613707

  • Cardiac sizing catheter

PTS® - 04046964311031

PTS404 PTS BALLOON 40MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613706
In Commercial Distribution

  • 04046964311031 ()
613706

  • Cardiac sizing catheter

PTS® - 04046964311017

PTS403 PTS BALLOON 40MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613705
In Commercial Distribution

  • 04046964311017 ()
613705

  • Cardiac sizing catheter

PTS® - 04046964310997

PTS305 PTS BALLOON 30MM X 5CM X 80 CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613704
In Commercial Distribution

  • 04046964310997 ()
613704

  • Cardiac sizing catheter

PTS® - 04046964310973

PTS304 PTS BALLOON 30MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613703
In Commercial Distribution

  • 04046964310973 ()
613703

  • Cardiac sizing catheter

PTS® - 04046964310959

PTS303 PTS BALLOON 30MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613702
In Commercial Distribution

  • 04046964310959 ()
613702

  • Cardiac sizing catheter

PTS® - 04046964310935

PTS253 PTS BALLOON 25MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613701
In Commercial Distribution

  • 04046964310935 ()
613701

  • Cardiac sizing catheter

PTS® - 04046964310911

PTS203 PTS BALLOON 20MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613700
In Commercial Distribution

  • 04046964310911 ()
613700

  • Cardiac sizing catheter

CARDINAL HEALTH - 20885380020282

H.pylori Rapid Test
Cardinal Health 200, LLC
B1077-25
Not in Commercial Distribution

  • 50885380020283 ()
  • 20885380020282 ()
  • 10885380020285 ()
B1077-25

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Lyher - 06972412619405

The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicatingrecent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Hangzhou Laihe Biotech Co.,Ltd.
303002
In Commercial Distribution

  • 06972412619405 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit - 06973774259803

No Description
Biohit Healthcare (Hefei) Co., Ltd.
25 Tests/Kit
In Commercial Distribution

  • 06973774259803 ()
  • 16973774259800 ()
REF:207.01.25.02

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

PRO ADVANTAGE - M220P0800953

PRO ADVANTAGE H PYLORI TEST TUBES 20TST/KT
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P080095
In Commercial Distribution

  • M220P0800955 ()
  • M220P0800953 ()
P080095

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

EasyFlow Duo Cannula - 00803622128073

No Description
LIVANOVA USA, INC.
Duo Cannula
In Commercial Distribution

  • 10803622128070 ()
  • 00803622128073 ()


  • Aorta cannula

Fastep COVID-19 IgG/IgM Rapid Test Device - 06952804805029

No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804805029 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Amplatzer™ - 00811806011530

Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-034
In Commercial Distribution

  • 00811806011530 ()

  • Length: 70.0000 Centimeter
  • Outer Diameter: 34.0000 Millimeter
9-SB-034

  • Cardiac sizing catheter

CARDINAL HEALTH - 10888439394740

G U MAJOR
Cardinal Health 200, LLC
PG5AMJKS2
In Commercial Distribution

  • 50888439394748 ()
  • 10888439394740 ()
PG5AMJKS2

  • General surgical procedure kit, medicated

IMMCO DIAGNOSTICS - 00845714001857

Celiac G+lgA
IMMCO DIAGNOSTICS, INC.
5159A
Not in Commercial Distribution

  • 00845714001857 ()

  • 96 Determinations
5159A

  • Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

IMMCO DIAGNOSTICS - 00845714001840

Celiac G+lgG
IMMCO DIAGNOSTICS, INC.
5159G
Not in Commercial Distribution

  • 00845714001840 ()

  • 96 Determinations
5159G

  • Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

Magenta - D7075830540

Magenta 50 g
IVOCLAR VIVADENT, INC.
583054
Not in Commercial Distribution

  • D7075830540 ()
583054

  • Dental casting noble alloy

W 1 - D7075830530

W-1 50 g
IVOCLAR VIVADENT, INC.
583053
Not in Commercial Distribution

  • D7075830530 ()
583053

  • Dental casting noble alloy

W. - D7075830510

W 50 g
IVOCLAR VIVADENT, INC.
583051
Not in Commercial Distribution

  • D7075830510 ()
583051

  • Dental casting noble alloy

Protocol - D7075829910

Protocol 100 g
IVOCLAR VIVADENT, INC.
582991
Not in Commercial Distribution

  • D7075829910 ()
582991

  • Dental casting noble alloy

Protocol - D7075829890

Protocol 25 g
IVOCLAR VIVADENT, INC.
582989
Not in Commercial Distribution

  • D7075829890 ()
582989

  • Dental casting noble alloy

Protocol - D7075829870

Protocol 5 g
IVOCLAR VIVADENT, INC.
582987
Not in Commercial Distribution

  • D7075829870 ()
582987

  • Dental casting noble alloy

W 1 - D7075829850

W-1 100 g
IVOCLAR VIVADENT, INC.
582985
In Commercial Distribution

  • D7075829850 ()
582985

  • Dental casting noble alloy

W 1 - D7075829830

W-1 25 g
IVOCLAR VIVADENT, INC.
582983
In Commercial Distribution

  • D7075829830 ()
582983

  • Dental casting noble alloy

W 1 - D7075829810

W-1 5 g
IVOCLAR VIVADENT, INC.
582981
In Commercial Distribution

  • D7075829810 ()
582981

  • Dental casting noble alloy

Spartan - D7075829730

Spartan 100 g
IVOCLAR VIVADENT, INC.
582973
Not in Commercial Distribution

  • D7075829730 ()
582973

  • Dental casting noble alloy

Spartan - D7075829710

Spartan 25 g
IVOCLAR VIVADENT, INC.
582971
Not in Commercial Distribution

  • D7075829710 ()
582971

  • Dental casting noble alloy

Spartan - D7075829690

Spartan 5 g
IVOCLAR VIVADENT, INC.
582969
Not in Commercial Distribution

  • D7075829690 ()
582969

  • Dental casting noble alloy

Leo - D7075829670

Leo 100 g
IVOCLAR VIVADENT, INC.
582967
Not in Commercial Distribution

  • D7075829670 ()
582967

  • Dental casting noble alloy

Leo - D7075829650

Leo 25 g
IVOCLAR VIVADENT, INC.
582965
Not in Commercial Distribution

  • D7075829650 ()
582965

  • Dental casting noble alloy

Leo - D7075829630

Leo 5 g
IVOCLAR VIVADENT, INC.
582963
Not in Commercial Distribution

  • D7075829630 ()
582963

  • Dental casting noble alloy

W2 - D7075829550

W-2 100 g
IVOCLAR VIVADENT, INC.
582955
In Commercial Distribution

  • D7075829550 ()
582955

  • Dental casting noble alloy

W2 - D7075829530

W-2 25 g
IVOCLAR VIVADENT, INC.
582953
In Commercial Distribution

  • D7075829530 ()
582953

  • Dental casting noble alloy

W2 - D7075829510

W-2 5 g
IVOCLAR VIVADENT, INC.
582951
In Commercial Distribution

  • D7075829510 ()
582951

  • Dental casting noble alloy

W 5 - D7075829490

W-5 100 g
IVOCLAR VIVADENT, INC.
582949
In Commercial Distribution

  • D7075829490 ()
582949

  • Dental casting noble alloy

W 5 - D7075829470

W-5 25 g
IVOCLAR VIVADENT, INC.
582947
In Commercial Distribution

  • D7075829470 ()
582947

  • Dental casting noble alloy

W 5 - D7075829440

W-5 5 g
IVOCLAR VIVADENT, INC.
582944
In Commercial Distribution

  • D7075829440 ()
582944

  • Dental casting noble alloy

W 3 - D7075829420

W-3 100 g
IVOCLAR VIVADENT, INC.
582942
In Commercial Distribution

  • D7075829420 ()
582942

  • Dental casting noble alloy

W 3 - D7075829400

W-3 25 g
IVOCLAR VIVADENT, INC.
582940
In Commercial Distribution

  • D7075829400 ()
582940

  • Dental casting noble alloy

W 3 - D7075829380

W-3 5 g
IVOCLAR VIVADENT, INC.
582938
In Commercial Distribution

  • D7075829380 ()
582938

  • Dental casting noble alloy

Y 1 - D7075829360

Y-1 100 g
IVOCLAR VIVADENT, INC.
582936
In Commercial Distribution

  • D7075829360 ()
582936

  • Dental casting noble alloy

Y 1 - D7075829340

Y-1 25 g
IVOCLAR VIVADENT, INC.
582934
In Commercial Distribution

  • D7075829340 ()
582934

  • Dental casting noble alloy

Y 1 - D7075829320

Y-1 5 g
IVOCLAR VIVADENT, INC.
582932
In Commercial Distribution

  • D7075829320 ()
582932

  • Dental casting noble alloy

Y. - D7075829180

Y 100 g
IVOCLAR VIVADENT, INC.
582918
In Commercial Distribution

  • D7075829180 ()
582918

  • Dental casting noble alloy

Y. - D7075829160

Y 25 g
IVOCLAR VIVADENT, INC.
582916
In Commercial Distribution

  • D7075829160 ()
582916

  • Dental casting noble alloy

Y. - D7075829140

Y 5 g
IVOCLAR VIVADENT, INC.
582914
In Commercial Distribution

  • D7075829140 ()
582914

  • Dental casting noble alloy

Elektra - D7075828880

Elektra 100 g
IVOCLAR VIVADENT, INC.
582888
In Commercial Distribution

  • D7075828880 ()
582888

  • Dental casting noble alloy

Elektra - D7075828860

Elektra 25 g
IVOCLAR VIVADENT, INC.
582886
In Commercial Distribution

  • D7075828860 ()
582886

  • Dental casting noble alloy
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