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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BB Retractor Right (Stainless Steel)
Modern Surgical Instruments LLC
769-08
In Commercial Distribution

  • 00810130200313 ()


  • Self-retaining surgical retractor, reusable
DIGITAL DERMAPAL BB 120V 60HZ
DAAVLIN DISTRIBUTING CO., THE
DIGITAL DERMAPAL
Not in Commercial Distribution

  • B280935DPBDT600 ()
935DPBDT60

  • Ultraviolet phototherapy unit, professional
Dermapal Digi BB 220V 50Hz
DAAVLIN DISTRIBUTING CO., THE
Dermapals
In Commercial Distribution

  • B2809935DPBDT50 ()


  • Ultraviolet phototherapy unit, professional
CUSTOM PACK BB11X80R2 BB PUMP
MEDTRONIC, INC.
BB11X80R2
In Commercial Distribution

  • 00763000715656 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11P03R CITRS BB
MEDTRONIC, INC.
BB11P03R
In Commercial Distribution

  • 00763000496944 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11X80R3 BB PUMP
MEDTRONIC, INC.
BB11X80R3
In Commercial Distribution

  • 00763000763985 ()


  • Cardiopulmonary bypass system blood tubing set
Monkey Heart 8 Well Slides, Pack of 12
MARDX DIAGNOSTICS, INC.
10-5408
In Commercial Distribution

  • 05391516747813 ()
10-5408

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Cardiac Positive Control, 0.5 mL
MARDX DIAGNOSTICS, INC.
10-5402
In Commercial Distribution

  • 05391516747806 ()
10-5402

  • Multiple cardiac marker IVD, control
Monkey Heart 4 Well Slides, 12 each/pack
MARDX DIAGNOSTICS, INC.
10-5404
In Commercial Distribution

  • 05391516747790 ()
10-5404

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Anti Cardiac Antibody IFA Test System, 48 Tests
MARDX DIAGNOSTICS, INC.
10-5448
In Commercial Distribution

  • 05391516747783 ()
10-5448

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-2
In Commercial Distribution

  • 00856743007031 ()
150-2

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150
In Commercial Distribution

  • 00856743007017 ()
150

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-3
In Commercial Distribution

  • 00856743007048 ()
150-3

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-1
In Commercial Distribution

  • 00856743007024 ()
150-1

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401db
In Commercial Distribution

  • 00859110005616 ()

  • 2 tests
401db

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401bc
In Commercial Distribution

  • 00859110005609 ()

  • 2 tests
401bc

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401ab
In Commercial Distribution

  • 00859110005593 ()

  • 2 tests
401ab

  • Multiple cardiac marker IVD, control
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1065x
In Commercial Distribution

  • 00867556000171 ()


  • 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
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401ro
In Commercial Distribution

  • 00850011135228 ()

  • 2 tests
401ro

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10431
In Commercial Distribution

  • 05055273217674 ()
CQ10431

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10430
In Commercial Distribution

  • 05055273217667 ()
CQ10430

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10429
In Commercial Distribution

  • 05055273217650 ()
CQ10429

  • Multiple cardiac marker IVD, control
This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10428
In Commercial Distribution

  • 05055273217346 ()
CQ10428

  • Multiple cardiac marker IVD, control
This product is intended for in vitro diagnostic use in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ3259
In Commercial Distribution

  • 05055273201857 ()


  • Multiple cardiac marker IVD, control
This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ3100
In Commercial Distribution

  • 05055273201840 ()


  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
27106X
In Commercial Distribution

  • 00847661004264 ()
27106X

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
27105X
In Commercial Distribution

  • 00847661004257 ()
27105X

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1A MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
27104X
In Commercial Distribution

  • 00847661004233 ()
27104X

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
148X
In Commercial Distribution

  • 00847661004226 ()
148X

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 2 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
147X
In Commercial Distribution

  • 00847661004219 ()
147X

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
146X
In Commercial Distribution

  • 00847661004202 ()
146X

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
27106
In Commercial Distribution

  • 00847661004196 ()
27106

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
27105
In Commercial Distribution

  • 00847661004189 ()
27105

  • Multiple cardiac marker IVD, control
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