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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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For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.
BIO-MED DIAGNOSTICS, INC.
1103
In Commercial Distribution

  • B08811034 ()
  • B08811030 ()
  • B08811032 ()
21-103-001

  • Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid
Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD
Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with limiter and Obturator, a water inflow tube, a collapsible waste segmented hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Segmented Hose / Hydrokit with limiter
In Commercial Distribution

  • B482Z161 ()
  • B482Z160 ()
  • B482Z162 ()
Z-16

  • Colonic lavage kit, non-surgical
Colon Hydrotherapy Disposable Single-Use Kit, consisting of a small size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Small Hydrokit
In Commercial Distribution

  • B482Z101 ()
  • B482Z100 ()
  • B482Z102 ()
Z-10

  • Colonic lavage kit, non-surgical
Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Large Hydrokit
In Commercial Distribution

  • B482Z091 ()
  • B482Z090 ()
  • B482Z092 ()
Z-09

  • Colonic lavage kit, non-surgical
Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste segmented hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Segmented Hose / Large Hydrokit
In Commercial Distribution

  • B482Z201 ()
  • B482Z200 ()
  • B482Z202 ()
Z-20

  • Colonic lavage kit, non-surgical
No Description
LED TECHNOLOGIES INC
RVGLOAC
In Commercial Distribution

  • B347RVGLOAC1 ()
  • B347RVGLOAC0 ()
  • B347RVGLOAC2 ()


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

  • B347FLJOINT1 ()
  • B347FLJOINT0 ()
  • B347FLJOINT2 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA570610
In Commercial Distribution

  • B347BA5706101 ()
  • B347BA5706100 ()
  • B347BA5706102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA568810
In Commercial Distribution

  • B347BA5688101 ()
  • B347BA5688100 ()
  • B347BA5688102 ()


  • Blue/red/infrared phototherapy lamp
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