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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Aerotech I Radioaerosol Administration System
BIODEX MEDICAL SYSTEMS, INC.
177-124
In Commercial Distribution

  • 00718175001240 ()
  • 30718175001272 ()
  • 20718175001268 ()
  • 10718175001254 ()
177-124

  • Radioaerosol administration set
Multiholder PK I DTS, Restoration
LM-Dental
750-756EST
In Commercial Distribution

  • 06438311036403 ()


  • Manual dental burnisher, reusable
Nyström I DTS, Carver, Restoration
LM-Dental
74-75EST
In Commercial Distribution

  • 06438311030746 ()


  • Dental restoration carver, resin
STND CLOSURE PACK BASIC I
MEDLINE INDUSTRIES, INC.
DYNJ67565A
In Commercial Distribution

  • 40195327293537 ()
  • 10195327293536 ()
DYNJ67565A

  • General surgical procedure kit, non-medicated, single-use
OPEN HEART PACK PART I
MEDLINE INDUSTRIES, INC.
DYNJ83706
In Commercial Distribution

  • 40195327299188 ()
  • 10195327299187 ()
DYNJ83706

  • General surgical procedure kit, non-medicated, single-use
OPEN HEART DRAPE I & II
AMERICAN CONTRACT SYSTEMS, INC.
CXCV03AX
In Commercial Distribution

  • 00191072187208 ()


  • General surgical procedure kit, non-medicated, single-use
OPEN HEART PACK PART I
AMERICAN CONTRACT SYSTEMS, INC.
CXCV01AX
In Commercial Distribution

  • 00191072187192 ()


  • General surgical procedure kit, non-medicated, single-use
CATH I W/ ANGIO DRAPE
MEDLINE INDUSTRIES, INC.
DYNJ33709D
In Commercial Distribution

  • 40888277282446 ()
  • 10888277282445 ()
DYNJ33709D

  • General surgical procedure kit, non-medicated, reusable
7013-8033 @DIEGO TURBINATOR BLADE, I
MEDLINE INDUSTRIES, INC.
REP104129
In Commercial Distribution

  • 10888277351530 ()

  • Outer Diameter: 2 Millimeter
REP104129

  • Arthroscopic shaver system blade, reprocessed
Sterilization Case I, Atrix-C, Instruments
Xtant Medical Holdings, Inc.
X094-0003
In Commercial Distribution

  • M697X09400030 ()
  • M697X09400031 ()


  • Cadaveric-donor bone allograft
Alinity I Intact PTH Calibrators
Abbott GmbH
08P3102
In Commercial Distribution

  • 00380740155360 ()
08P3102

  • Parathyroid hormone (PTH) IVD, calibrator
Alinity i AFP Assay File
Abbott GmbH
07P901B
In Commercial Distribution

  • 00380740154455 ()
07P901B

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgQu Assay File
Abbott GmbH
08P103A
In Commercial Distribution

  • 00380740154394 ()
08P103A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HCVUS Assay File
Abbott GmbH
08P051A
In Commercial Distribution

  • 00380740154370 ()
08P051A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HBcUS Assay File
Abbott GmbH
07P841A
In Commercial Distribution

  • 00380740154356 ()
07P841A

  • Laboratory instrument/analyser application software IVD
Alinity c ASO Control I
ABBOTT LABORATORIES
04S0912
In Commercial Distribution

  • 00380740153748 ()
04S0912

  • Plasma protein IVD, control
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
04P5518
Not in Commercial Distribution

  • 00380740153434 ()
04P5518

  • Laboratory instrument/analyser application software IVD
Alinity i Sirolimus Assay File
Abbott GmbH
09P411A
In Commercial Distribution

  • 00380740151744 ()
09P411A

  • Laboratory instrument/analyser application software IVD
Alinity i Progest Assay File
Abbott GmbH
08P361A
In Commercial Distribution

  • 00380740151706 ()
08P361A

  • Laboratory instrument/analyser application software IVD
Alinity i LH Assay File
Abbott GmbH
07P911A
In Commercial Distribution

  • 00380740151621 ()
07P911A

  • Laboratory instrument/analyser application software IVD
Alinity i tHCY-UNDIL Assay File
Abbott GmbH
09P281A
In Commercial Distribution

  • 00380740151607 ()
09P281A

  • Laboratory instrument/analyser application software IVD
Alinity i DHEA-S Assay File
Abbott GmbH
09P371A
In Commercial Distribution

  • 00380740151515 ()
09P371A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-TPO Assay File
Abbott GmbH
09P351A
In Commercial Distribution

  • 00380740151430 ()
09P351A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-CCP Assay File
Abbott GmbH
09P271A
In Commercial Distribution

  • 00380740151416 ()
09P271A

  • Laboratory instrument/analyser application software IVD
Alinity i SHBG Reagent Kit
Abbott GmbH
09P3820
In Commercial Distribution

  • 00380740151393 ()
09P3820

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Alinity i Active-B12 (Holotranscobalamin) Calibrators
Abbott GmbH
09P2601
In Commercial Distribution

  • 00380740150501 ()
09P2601

  • Vitamin B12 IVD, calibrator
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-17
Not in Commercial Distribution

  • 00380740150143 ()
04P5517

  • Laboratory instrument/analyser application software IVD
Alinity i iPTH Assay File
Abbott GmbH
08P311A
In Commercial Distribution

  • 00380740146658 ()
08P311A

  • Laboratory instrument/analyser application software IVD
Alinity i HE4 Assay File
Abbott GmbH
08P501A
In Commercial Distribution

  • 00380740146610 ()
08P501A

  • Laboratory instrument/analyser application software IVD
Alinity i Estradiol Assay File
Abbott GmbH
07P501A
In Commercial Distribution

  • 00380740143091 ()
07P501A

  • Laboratory instrument/analyser application software IVD
Alinity i Prolactin Assay File
Abbott GmbH
07P661A
In Commercial Distribution

  • 00380740143084 ()
07P661A

  • Laboratory instrument/analyser application software IVD
Alinity i Syphilis Assay File
Abbott GmbH
07P601A
In Commercial Distribution

  • 00380740143008 ()
07P601A

  • Laboratory instrument/analyser application software IVD
Alinity i Folate Assay File
Abbott GmbH
08P141A
In Commercial Distribution

  • 00380740142933 ()
08P141A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-16
Not in Commercial Distribution

  • 00380740139520 ()
04P5516

  • Laboratory instrument/analyser application software IVD
Alinity i Progesterone Manual Diluent
ABBOTT IRELAND
08P3640
In Commercial Distribution

  • 00380740136710 ()
08P3640

  • Progesterone IVD, kit, chemiluminescent immunoassay
Alinity i Intact PTH Controls
Abbott GmbH
08P3110
Not in Commercial Distribution

  • 00380740136208 ()
08P3110

  • Parathyroid hormone (PTH) IVD, control
Alinity i CA 19-9XR Controls
Abbott GmbH
08P3210
In Commercial Distribution

  • 00380740135492 ()
08P3210

  • Cancer antigen 19-9 (CA19-9) IVD, control
Alinity i Multi-Assay Manual Diluent
Abbott Ireland Diagnostics
09P1540
In Commercial Distribution

  • 00380740131678 ()
09P1540

  • Buffered sample diluent IVD
Alinity i HAVAb IgM Controls
Abbott GmbH
08P2810
In Commercial Distribution

  • 00380740131579 ()
08P2810

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
Alinity i Total T4 Controls
ABBOTT IRELAND
07P9510
In Commercial Distribution

  • 00380740131500 ()
07P9510

  • Total thyroxine (TT4) IVD, control
Alinity i Total T4 Calibrators
ABBOTT IRELAND
07P9501
In Commercial Distribution

  • 00380740131494 ()
07P9501

  • Total thyroxine (TT4) IVD, calibrator
Alinity i HAVAb IgG Calibrator
Abbott GmbH
08P2701
In Commercial Distribution

  • 00380740131357 ()
08P2701

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
Alinity i Free T3 Controls
ABBOTT IRELAND
07P6910
In Commercial Distribution

  • 00380740131098 ()
07P6910

  • Free triiodothyronine (FT3) IVD, control
Alinity i GFAP Assay File
Abbott GmbH
04W171B
In Commercial Distribution

  • 00380740208929 ()
04W171B

  • Laboratory instrument/analyser application software IVD
Alinity i Toxo IgG Calibrators
Abbott GmbH
07P4504
In Commercial Distribution

  • 00380740203177 ()
07P4504

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, calibrator
Alinity i HBsAgNx_C1 Assay File
Abbott GmbH
01R658A
In Commercial Distribution

  • 00380740202903 ()
01R658A

  • Laboratory instrument/analyser application software IVD
Alinity i CMV IgG Controls
Abbott Ireland Diagnostics
07P4212
In Commercial Distribution

  • 00380740180973 ()
07P4212

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
Alinity i CMV IgG Calibrators
Abbott Ireland Diagnostics
07P4202
In Commercial Distribution

  • 00380740180966 ()
07P4202

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, calibrator
Alinity i Toxo IgG Controls
Abbott GmbH
07P4514
In Commercial Distribution

  • 00380740174347 ()
07P4514

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Alinity i STAT Myoglobin Controls
Abbott Ireland Diagnostics
04V3710
In Commercial Distribution

  • 00380740172282 ()
04V3710

  • Myoglobin IVD, control
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