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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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No Description
LED TECHNOLOGIES INC
BA568110
In Commercial Distribution

  • B347BA5681101 ()
  • B347BA5681100 ()
  • B347BA5681102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567410
In Commercial Distribution

  • B347BA5674102 ()
  • B347BA5674101 ()
  • B347BA5674100 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567210
Not in Commercial Distribution

  • B347BA5672101 ()
  • B347BA5672100 ()
  • B347BA5672102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567010
Not in Commercial Distribution

  • B347BA5670102 ()
  • B347BA5670101 ()
  • B347BA5670100 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
5756
In Commercial Distribution

  • B34757561 ()
  • B34757560 ()
  • B34757562 ()


  • Blue/red/infrared phototherapy lamp
HR Wide angle lens Consultation
PHAKOS
MV LV 41 HR
In Commercial Distribution

  • B564MVLV41HR2 ()
  • B564MVLV41HR0 ()
  • B564MVLV41HR4 ()
MV LV 41 HR

  • Vitrectomy contact lens, single-use
Disposable Retinal Cryo Probe
PHAKOS
MV CY 100
In Commercial Distribution

  • B564MVCY1000 ()
  • B564MVCY1002 ()
  • B564MVCY1004 ()
MV CY 100

  • General cryosurgical system, cryogen gas, mechanical
The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The BiWaze Clear System may be used with a patient interface like face mask, mouthpiece, a trach adapter to a patient’s endotracheal or tracheostomy tube. It is for use on adult or paediatric patients in acute, post-acute, and home care environments. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting
Abmrc LLC
BK181
In Commercial Distribution

  • B965BK367 ()
  • B965BK181 ()
  • B965BK368 ()
BK181

  • In-exsufflation/lung-oscillation airway secretion-clearing system
Disposable Bipolar Cord Straight 12 FT
STINGRAY SURGICAL PRODUCTS, LLC
S04-800
Not in Commercial Distribution

  • B112S048000 ()
  • B112S048001 ()
  • B112S048002 ()


  • Electrical-only medical device connection cable, single-use
BUSULFAN 25 NG/ML
UTAK LABORATORIES, INC.
BUS 25 V P F CHLA
In Commercial Distribution

  • B800BUS25VPFCHLA5 ()
  • B800BUS25VPFCHLA0 ()
  • B800BUS25VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 25 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
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