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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Nyström I, Carver, Restoration
LM-Dental
74-75ES
In Commercial Distribution

  • 06438311219738 ()


  • Dental restoration carver, resin
I R MICROSPHERE PACK
MEDLINE INDUSTRIES, INC.
DYNJ82185B
In Commercial Distribution

  • 40195327449668 ()
  • 10195327449667 ()
DYNJ82185B

  • General surgical procedure kit, non-medicated, single-use
NMH I R PORT
MEDLINE INDUSTRIES, INC.
CVI4890A
In Commercial Distribution

  • 40195327699032 ()
  • 10195327699031 ()
CVI4890A

  • General surgical procedure kit, non-medicated, single-use
MINOR PLUS I PACK
MEDLINE INDUSTRIES, INC.
DYNJ43373
In Commercial Distribution

  • 10888277047389 ()
  • 40888277047380 ()
DYNJ43373

  • General surgical procedure kit, non-medicated, reusable
INSTRUMENT CASSETTE MARK I
PREMIER DENTAL PRODUCTS COMPANY
9010904
In Commercial Distribution

  • 00348783011487 ()


  • Device sterilization/disinfection container, reusable
Alinity i AFP Calibrators
Abbott Ireland Diagnostics
07P9001
In Commercial Distribution

  • 00380740130794 ()
07P9001

  • Alpha-fetoprotein (AFP) IVD, calibrator
Alinity i Anti-HCV Controls
Abbott GmbH
08P0510
In Commercial Distribution

  • 00380740130640 ()
08P0510

  • Hepatitis C virus total antibody IVD, control
Alinity i Anti-HCV Calibrator
Abbott GmbH
08P0501
In Commercial Distribution

  • 00380740130633 ()
08P0501

  • Hepatitis C virus total antibody IVD, calibrator
Alinity i Cortisol Calibrators
Abbott Ireland Diagnostics
08P3301
In Commercial Distribution

  • 00380740130046 ()
08P3301

  • Total cortisol IVD, calibrator
Alinity i Estradiol Controls
ABBOTT IRELAND
07P5010
In Commercial Distribution

  • 00380740129903 ()
07P5010

  • Estradiol (oestradiol) (E2) IVD, control
Alinity i Estradiol Calibrators
ABBOTT IRELAND
07P5001
In Commercial Distribution

  • 00380740129897 ()
07P5001

  • Estradiol (oestradiol) (E2) IVD, calibrator
Alinity i Progesterone Controls
ABBOTT IRELAND
08P3610
In Commercial Distribution

  • 00380740121860 ()
08P3610

  • Progesterone IVD, control
Alinity i Progesterone Calibrators
ABBOTT IRELAND
08P3601
In Commercial Distribution

  • 00380740121853 ()
08P3601

  • Progesterone IVD, calibrator
Alinity i Prolactin Controls
ABBOTT IRELAND
07P6610
In Commercial Distribution

  • 00380740121563 ()
07P6610

  • Prolactin IVD, control
Alinity i Prolactin Calibrators
ABBOTT IRELAND
07P6601
In Commercial Distribution

  • 00380740121556 ()
07P6601

  • Prolactin IVD, calibrator
Alinity i LH Calibrators
ABBOTT IRELAND
07P9101
In Commercial Distribution

  • 00380740121525 ()
07P9101

  • Luteinizing hormone (LH) IVD, calibrator
Quantia ASO Control I
ABBOTT LABORATORIES
6K54-21
In Commercial Distribution

  • 00380740044831 ()
06K5421

  • Plasma protein IVD, control
Alinity i Homocysteine Controls
Abbott GmbH
09P2810
In Commercial Distribution

  • 00380740154486 ()
09P2810

  • Homocysteine IVD, control
Alinity i Homocysteine Calibrators
Abbott GmbH
09P2801
In Commercial Distribution

  • 00380740154479 ()
09P2801

  • Homocysteine IVD, calibrator
Alinity i C-Peptide Calibrators
Abbott GmbH
09P3601
In Commercial Distribution

  • 00380740154462 ()
09P3601

  • C-peptide IVD, calibrator
Alinity i SHBG Controls
Abbott GmbH
09P3810
In Commercial Distribution

  • 00380740151386 ()
09P3810

  • Sex hormone binding globulin (SHBG) IVD, control
Alinity i SHBG Calibrators
Abbott GmbH
09P3801
In Commercial Distribution

  • 00380740151379 ()
09P3801

  • Sex hormone binding globulin (SHBG) IVD, calibrator
Alinity i Anti-CCP Controls
Abbott GmbH
09P2710
In Commercial Distribution

  • 00380740151355 ()
09P2710

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
Alinity i Anti-CCP Calibrators
Abbott GmbH
09P2701
In Commercial Distribution

  • 00380740151348 ()
09P2701

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, calibrator
Alinity i Anti-HBs Controls
Abbott Ireland Diagnostics
07P8810
In Commercial Distribution

  • 00380740151300 ()
07P8810

  • Hepatitis B virus surface total antibody IVD, control
Alinity i Tacrolimus Calibrators
Abbott Ireland Diagnostics
09P4201
In Commercial Distribution

  • 00380740151010 ()
09P4201

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Alinity i Sirolimus Calibrators
Abbott Ireland Diagnostics
09P4101
In Commercial Distribution

  • 00380740150983 ()
09P4101

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator
Alinity i Insulin Controls
Abbott GmbH
04T7510
In Commercial Distribution

  • 00380740150808 ()
04T7510

  • Insulin IVD, control
Alinity i Insulin Calibrators
Abbott GmbH
04T7501
In Commercial Distribution

  • 00380740150792 ()
04T7501

  • Insulin IVD, calibrator
Alinity i DHEA-S Controls
Abbott GmbH
09P3710
In Commercial Distribution

  • 00380740150631 ()
09P3710

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
Alinity i Anti-TPO Controls
Abbott Ireland Diagnostics
09P3510
In Commercial Distribution

  • 00380740150600 ()
09P3510

  • Multiple thyroid antibody IVD, control
Alinity i Anti-Tg Controls
Abbott Ireland Diagnostics
09P3410
In Commercial Distribution

  • 00380740150587 ()
09P3410

  • Thyroglobulin antibody IVD, control
Alinity i Anti-HBs Calibrators
Abbott Ireland Diagnostics
07P8801
In Commercial Distribution

  • 00380740149574 ()
07P8801

  • Hepatitis B virus surface total antibody IVD, calibrator
Alinity i Anti-HBc Calibrator
Abbott GmbH
07P8401
In Commercial Distribution

  • 00380740136635 ()
07P8401

  • Hepatitis B virus core total antibody IVD, calibrator
Alinity i Folate Controls
ABBOTT IRELAND
08P1412
In Commercial Distribution

  • 00380740136543 ()
08P1412

  • Folate (vitamin B9) IVD, control
Alinity i Folate Calibrators
ABBOTT IRELAND
08P1402
In Commercial Distribution

  • 00380740136536 ()
08P1402

  • Folate (vitamin B9) IVD, calibrator
Alinity i T-Uptake Controls
Abbott Ireland Diagnostics
08P1210
In Commercial Distribution

  • 00380740135478 ()
08P1210

  • Multiple thyroid hormone uptake (T-uptake) IVD, control
Alinity i CMV IgG
Abbott GmbH
07P425A
In Commercial Distribution

  • 00380740202002 ()
07P425A

  • Laboratory instrument/analyser application software IVD
Alinity i Toxo IgG
Abbott GmbH
07P455A
In Commercial Distribution

  • 00380740201975 ()
07P455A

  • Laboratory instrument/analyser application software IVD
Quantia ASO Control I
ABBOTT LABORATORIES
06K5422
In Commercial Distribution

  • 00380740156381 ()
06K5422

  • Plasma protein IVD, control
Alinity i C-Peptide Controls
Abbott GmbH
09P3610
In Commercial Distribution

  • 00380740153526 ()
09P3610

  • C-peptide IVD, control
Alinity i DHEA-S Calibrators
Abbott GmbH
09P3701
In Commercial Distribution

  • 00380740150624 ()
09P3701

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, calibrator
Alinity i Anti-TPO Calibrators
Abbott Ireland Diagnostics
09P3501
In Commercial Distribution

  • 00380740150594 ()
09P3501

  • Multiple thyroid antibody IVD, calibrator
Alinity i Anti-Tg Calibrators
Abbott Ireland Diagnostics
09P3401
In Commercial Distribution

  • 00380740150570 ()
09P3401

  • Thyroglobulin antibody IVD, calibrator
Alinity i Processing Module
ABBOTT LABORATORIES
03R6501
In Commercial Distribution

  • 00380740137366 ()
03R6501

  • Chemiluminescent immunoassay analyser IVD
Alinity i B12 Controls
ABBOTT IRELAND
07P6712
In Commercial Distribution

  • 00380740136680 ()
07P6712

  • Vitamin B12 IVD, control
Alinity i B12 Calibrators
ABBOTT IRELAND
07P6702
In Commercial Distribution

  • 00380740136673 ()
07P6702

  • Vitamin B12 IVD, calibrator
Alinity i Anti-HBc Controls
Abbott GmbH
07P8410
In Commercial Distribution

  • 00380740136642 ()
07P8410

  • Hepatitis B virus core total antibody IVD, control
Alinity i HE4 Controls
Abbott GmbH
08P5010
In Commercial Distribution

  • 00380740135423 ()
08P5010

  • Human epididymis protein 4 (HE4) IVD, control
Alinity i AFP Controls
Abbott Ireland Diagnostics
07P9010
In Commercial Distribution

  • 00380740130800 ()
07P9010

  • Alpha-fetoprotein (AFP) IVD, control
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