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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GENUMEDI SILVER SIZE I
MEDI MANUFACTURING, INC.
K102201
In Commercial Distribution

  • 04049772814640 ()


  • Knee support orthosis
GENUMEDI SAND SIZE I
MEDI MANUFACTURING, INC.
K102801
In Commercial Distribution

  • 04049772814527 ()


  • Knee support orthosis
CV I II,KIT
Cardinal Health 200, LLC
PC23OHRMK
In Commercial Distribution

  • 50887488276821 ()
  • 10887488276823 ()
PC23OHRMK

  • Cardiothoracic surgical procedure kit, medicated, single-use
STERILE HEART I PACK
Cardinal Health 200, LLC
SCVW1HIMPA
In Commercial Distribution

  • 50887488527435 ()
  • 10887488527437 ()
SCVW1HIMPA

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
KNEE ARTHROSCOPY I PACK
Cardinal Health 200, LLC
SOP31KAMNJ
In Commercial Distribution

  • 50887488576563 ()
  • 10887488576565 ()
SOP31KAMNJ

  • Arthroscopic surgical procedure kit, medicated
STERILE CYSTOSCOPY I PACK
Cardinal Health 200, LLC
SBA7CCYYNB
In Commercial Distribution

  • 50887488339250 ()
  • 10887488339252 ()
SBA7CCYYNB

  • Urological surgical procedure kit, non-medicated, single-use
STERILE I J PACK
Cardinal Health 200, LLC
SAN47IJSF1
In Commercial Distribution

  • 50887488326243 ()
  • 10887488326245 ()
SAN47IJSF1

  • Angiography kit
STERILE CESAREAN I PACK
Cardinal Health 200, LLC
SMA30CCPRG
In Commercial Distribution

  • 50887488347484 ()
  • 10887488347486 ()
SMA30CCPRG

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
GENUMEDI PSS GREEN I
MEDI MANUFACTURING, INC.
K150401
In Commercial Distribution

  • 04051526768451 ()


  • Knee support orthosis
PLIF side impactor I
SPINECRAFT, LLC
7040-05-1
In Commercial Distribution

  • 00193082078682 ()
7040-05-1

  • General internal orthopaedic fixation system implantation kit
CV I II,KIT
Cardinal Health 200, LLC
PC23OHRML
In Commercial Distribution

  • 50887488376996 ()
  • 10887488376998 ()
PC23OHRML

  • Cardiothoracic surgical procedure kit, medicated, single-use
STERILE KAIR I PACK
Cardinal Health 200, LLC
SAN45SAKPI
In Commercial Distribution

  • 50887488464334 ()
  • 10887488464336 ()
SAN45SAKPI

  • Cardiothoracic surgical procedure kit, medicated, single-use
STERILE EYE I PACK
Cardinal Health 200, LLC
SEY35EYSSB
In Commercial Distribution

  • 50887488511373 ()
  • 10887488511375 ()
SEY35EYSSB

  • Ophthalmic surgical procedure kit, non-medicated, single-use
KIT,I AND D
Cardinal Health 200, LLC
PGMHIDBHF
In Commercial Distribution

  • 50887488503088 ()
  • 10887488503080 ()
PGMHIDBHF

  • General surgical procedure kit, medicated
STERILE BASIC I PACK
Cardinal Health 200, LLC
SBA42BPFMA
In Commercial Distribution

  • 50887488495109 ()
  • 10887488495101 ()
SBA42BPFMA

  • General surgical procedure kit, non-medicated, single-use
CV I II, KIT
Cardinal Health 200, LLC
PC23OHRMM
In Commercial Distribution

  • 50887488553960 ()
  • 10887488553962 ()
PC23OHRMM

  • Cardiothoracic surgical procedure kit, medicated, single-use
STERILE I D TRAY
Cardinal Health 200, LLC
08-4490B
In Commercial Distribution

  • 50887488220268 ()
  • 10887488220260 ()
08-4490B

  • General surgical procedure kit, medicated
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 Progesterone Controls
ABBOTT IRELAND
08P3610
In Commercial Distribution

  • 00380740121860 ()
08P3610

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

  • 00380740121556 ()
07P6601

  • Prolactin IVD, calibrator
CATH LAB PACK I
MEDLINE INDUSTRIES, INC.
DYNJHTCLAB6
In Commercial Distribution

  • 10888277078802 ()
  • 40888277078803 ()
DYNJHTCLAB6

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

  • 00348783011487 ()


  • Device sterilization/disinfection container, reusable
MINOR PLUS I PACK
MEDLINE INDUSTRIES, INC.
DYNJ43373
In Commercial Distribution

  • 10888277047389 ()
  • 40888277047380 ()
DYNJ43373

  • General surgical procedure kit, non-medicated, reusable
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 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 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
Enzyme I Calibrator, 2x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10284680
In Commercial Distribution

  • 00842768026218 ()
  • 00630414602004 ()
DC35

  • Multiple clinical chemistry enzyme IVD, calibrator
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 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 C-Peptide Controls
Abbott GmbH
09P3610
In Commercial Distribution

  • 00380740153526 ()
09P3610

  • C-peptide IVD, control
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 Processing Module
ABBOTT LABORATORIES
03R6501
In Commercial Distribution

  • 00380740137366 ()
03R6501

  • Chemiluminescent immunoassay analyser IVD
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