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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Liquichek Cardiac Troponins Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12001084
In Commercial Distribution

  • 03610520551356 ()
12001084

  • Multiple cardiac marker IVD, control
PBM Cardiac Marker Control Set (2 x 1 mL)
PRINCETON BIOMEDITECH CORPORATION
LSC-300C-01
In Commercial Distribution

  • 10743816001607 ()
LSC-300C-01

  • Multiple cardiac marker IVD, control
PBM Cardiac Marker Control Set (2 x 1 mL)
PRINCETON BIOMEDITECH CORPORATION
LSC-301
In Commercial Distribution

  • 10743816001355 ()
LSC-301

  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-MP
In Commercial Distribution

  • 00884883012004 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-SP
In Commercial Distribution

  • 00884883011991 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-303
In Commercial Distribution

  • 00884883011984 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-202
In Commercial Distribution

  • 00884883011977 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-101
In Commercial Distribution

  • 00884883011960 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-L
In Commercial Distribution

  • 00884883011953 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-UL
In Commercial Distribution

  • 00884883011946 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014182
In Commercial Distribution

  • 00884883004399 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014181
In Commercial Distribution

  • 00884883004382 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014180
In Commercial Distribution

  • 00884883004375 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014179
In Commercial Distribution

  • 00884883004368 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XLS
In Commercial Distribution

  • 00884883003613 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL4
In Commercial Distribution

  • 00884883003606 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XLL
In Commercial Distribution

  • 00884883002371 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL3
In Commercial Distribution

  • 00884883002364 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL2
In Commercial Distribution

  • 00884883002357 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL1
In Commercial Distribution

  • 00884883002340 ()


  • Multiple cardiac marker IVD, control
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1066x
In Commercial Distribution

  • 00867556000195 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1065
In Commercial Distribution

  • 00867556000188 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1066
In Commercial Distribution

  • 00867556000157 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 120 Tests
Siemens Healthcare Diagnostics Inc.
10464339
In Commercial Distribution

  • 00842768027918 ()
  • 00630414005577 ()
K3032

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444895
In Commercial Distribution

  • 00842768013898 ()
  • 00630414003863 ()
RF520

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10444904
In Commercial Distribution

  • 00842768013829 ()
  • 00630414003924 ()
RF420

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma.
BIOMERIEUX SA
30421-01
Not in Commercial Distribution

  • 03573026161613 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
BB 40K DELUXE SECTIONAL LATCH ANGLE
Young Innovations, Inc.
BB40U
In Commercial Distribution

  • 10840326416768 ()
  • 00840326416761 ()
BB40U

  • Dental power tool handpiece motorless component
BB 12 L 10 to 60
NOVATECH
026951R
In Commercial Distribution

  • EBES026951R0 ()
026951R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 12 L 10 to 60
NOVATECH
026951
In Commercial Distribution

  • EBES0269510 ()
  • EBES0269511 ()
026951

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 11 L 10 to 60
NOVATECH
026901R
Not in Commercial Distribution

  • EBES026901R0 ()
026901R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 11 L 10 to 60
NOVATECH
026901
Not in Commercial Distribution

  • EBES0269010 ()
  • EBES0269011 ()
026901

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 10 L 10 to 60
NOVATECH
026801R
Not in Commercial Distribution

  • EBES026801R0 ()
026801R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 10 L 10 to 60
NOVATECH
026801
Not in Commercial Distribution

  • EBES0268010 ()
  • EBES0268011 ()
026801

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 09 L 10 to 60
NOVATECH
026751R
Not in Commercial Distribution

  • EBES026751R0 ()
026751R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 09 L 10 to 60
NOVATECH
026751
Not in Commercial Distribution

  • EBES0267510 ()
  • EBES0267511 ()
026751

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 7X8 L 10 to 50
NOVATECH
026701R
Not in Commercial Distribution

  • EBES026701R0 ()
026701R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 7X8 L 10 to 50
NOVATECH
026701
Not in Commercial Distribution

  • EBES0267010 ()
  • EBES0267011 ()
026701

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 6X7 L 10 to 50
NOVATECH
026501R
Not in Commercial Distribution

  • EBES026501R0 ()
026501R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 6X7 L 10 to 50
NOVATECH
026501
Not in Commercial Distribution

  • EBES0265010 ()
  • EBES0265011 ()
026501

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 5X6 L 10 to 50
NOVATECH
026201R
Not in Commercial Distribution

  • EBES026201R0 ()
026201R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 5X6 L 10 to 50
NOVATECH
026201
Not in Commercial Distribution

  • EBES0262010 ()
  • EBES0262011 ()
026201

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 4X5 L 10 to 50
NOVATECH
025301R
Not in Commercial Distribution

  • EBES025301R0 ()
025301R

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 4X5 L 10 to 50
NOVATECH
025301
Not in Commercial Distribution

  • EBES0253010 ()
  • EBES0253011 ()
025301

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
78" ME w/BB PVC Tubes
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 00840106902125 ()
  • 00840106902095 ()
  • 00840106902118 ()
  • 00840106902101 ()
ME-070-03-204

  • Gas-sampling/monitoring respiratory tubing, single-use
KNAPP IRIS SCS 4 CVD BB
Avalign Technologies, Inc.
1-360095
In Commercial Distribution

  • 00190776302740 ()


  • Ophthalmic suture scissors
SKLIT XD STEVENS CVD BB 4.5
SKLAR CORPORATION
23-1161
In Commercial Distribution

  • 10649111148156 ()


  • General-purpose surgical scissors, reusable
SKLIT XD STEVENS STR BB 4.5
SKLAR CORPORATION
23-1160
In Commercial Distribution

  • 10649111148033 ()


  • General-purpose surgical scissors, reusable
SKLIT STEVENS SCIS CVD BB 4.5"
SKLAR CORPORATION
23-1157
In Commercial Distribution

  • 10649111147661 ()


  • General-purpose surgical scissors, reusable
SKLIT STEVENS SCIS STR BB 4.5
SKLAR CORPORATION
23-1156
In Commercial Distribution

  • 10649111147395 ()


  • General-purpose surgical scissors, reusable
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