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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TITAN 3 BB LATCH ANGLE
DENTALEZ, INC.
259005
In Commercial Distribution

  • D7022590050 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
Sims Scissors 8" Str, BB
Avalign Technologies, Inc.
1-505402
In Commercial Distribution

  • 00190776302382 ()


  • General-purpose surgical scissors, reusable
FLOOR GRADE OR SCISSORS BB .
Avalign Technologies, Inc.
FG-105
In Commercial Distribution

  • 00190776187132 ()


  • General-purpose surgical scissors, reusable
Operating Dissection Scissor, CVD, . BB
Avalign Technologies, Inc.
1-060C
In Commercial Distribution

  • 00190776185916 ()


  • General-purpose surgical scissors, reusable
Obwegeser-Freer periosteal elevator, DE, BB
Avalign Technologies, Inc.
1-99690
In Commercial Distribution

  • 00190776171681 ()


  • Bone lever/elevator, reusable
OPER. SCISS. 5" CVD. BB
ORTHO-MED, INC.
OM 33-0486
In Commercial Distribution

  • B8033304860 ()


  • General-purpose surgical scissors, reusable
OPER. SCISS. 5" STR. BB
ORTHO-MED, INC.
OM 33-0314
In Commercial Distribution

  • B8033303140 ()


  • General-purpose surgical scissors, reusable
Joseph/Meredith BB Removal Forceps
SYNERGETICS USA, INC.
11.40
In Commercial Distribution

  • 10841305103747 ()
11.40

  • Ophthalmic soft-tissue manipulation forceps, probe-like, reusable
ARTERIAL FILTER BB4014PEDS BB STERILE
MEDTRONIC, INC.
BB4014
In Commercial Distribution

  • 20613994617327 ()
  • 00613994617323 ()


  • Cardiopulmonary bypass system filter, arterial blood line
DRESSING SCISSOR CURVED 5.5 BB
Cardinal Health 200, LLC
FGS-030
In Commercial Distribution

  • 50888439920596 ()
  • 10888439920598 ()
FGS-030

  • General-purpose surgical scissors, single-use
BB X-RAY OVERHEAD TUBE SUSPENSION
GE Hualun Medical Systems Co., Ltd
5135678-9
In Commercial Distribution

  • 00195278569813 ()


  • Stationary basic diagnostic x-ray system, digital
BB X-RAY OVERHEAD TUBE SUSPENSION
GE Hualun Medical Systems Co., Ltd
5135678-10
In Commercial Distribution

  • 00195278569745 ()


  • Stationary basic diagnostic x-ray system, digital
Scissors Operating Room Cvd BB
HENRY SCHEIN, INC.
1049957
In Commercial Distribution

  • 00304040023297 ()
1049957

  • General-purpose surgical scissors, reusable
Scissors Operating Room STR BB
HENRY SCHEIN, INC.
1048232
In Commercial Distribution

  • 00304040023099 ()
1048232

  • General-purpose surgical scissors, reusable
OXYGENATOR BBP211 NI BB STERILE
MEDTRONIC, INC.
BBP211
In Commercial Distribution

  • 20613994617310 ()
  • 00613994617316 ()


  • Extracorporeal membrane oxygenator
CUSTOM PACK BB12P67R1 BB PEDIMAG
MEDTRONIC, INC.
BB12P67R1
In Commercial Distribution

  • 00199150015337 ()


  • Cardiopulmonary bypass system blood tubing set
BB, 22U Tp w/FlushPort
ARTHREX, INC.
AR-11890F
In Commercial Distribution

  • 00888867271128 ()
AR-11890F

  • Suturing unit, reusable
Dermapal Digi BB 220V 50Hz
DAAVLIN DISTRIBUTING CO., THE
Dermapals
In Commercial Distribution

  • B2809935DPBDT50 ()


  • Ultraviolet phototherapy unit, professional
DIGITAL DERMAPAL BB 120V 60HZ
DAAVLIN DISTRIBUTING CO., THE
DIGITAL DERMAPAL
Not in Commercial Distribution

  • B280935DPBDT600 ()
935DPBDT60

  • Ultraviolet phototherapy unit, professional
BB Retractor Offset (Stainless Steel)
Modern Surgical Instruments LLC
769-18
In Commercial Distribution

  • 00810130200337 ()


  • Self-retaining surgical retractor, reusable
BB Retractor Left (Stainless Steel)
Modern Surgical Instruments LLC
769-13
In Commercial Distribution

  • 00810130200320 ()


  • Self-retaining surgical retractor, reusable
BB Retractor Right (Stainless Steel)
Modern Surgical Instruments LLC
769-08
In Commercial Distribution

  • 00810130200313 ()


  • Self-retaining surgical retractor, reusable
CUSTOM PACK BB11X80R3 BB PUMP
MEDTRONIC, INC.
BB11X80R3
In Commercial Distribution

  • 00763000763985 ()


  • Cardiopulmonary bypass system blood tubing set
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
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
150-2
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
150-1
In Commercial Distribution

  • 00856743007024 ()
150-1

  • 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
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
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
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
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
InteliQ Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016487
In Commercial Distribution

  • 03610522248902 ()
12016487

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016486
In Commercial Distribution

  • 03610522248896 ()
12016486

  • Multiple cardiac marker IVD, control
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