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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Phototherapy Unit. UVB Narrowband. Single upright panel with Four 72" lamps. Mounts to wall or stand.
Medtek Lighting Corporation
40B
In Commercial Distribution

  • B343B40 ()

  • Area/Surface Area: 1311 Square inch
  • Weight: 150 Pound
40B

  • Ultraviolet phototherapy unit, professional
Phototherapy Unit. UVB Narrowband. Single upright panel with 10 lamps. Mounts to wall or to stand.
Medtek Lighting Corporation
100B
In Commercial Distribution

  • B343B100 ()

  • Area/Surface Area: 1311 Square inch
  • Weight: 180 Pound
100B

  • Ultraviolet phototherapy unit, professional
No Description
Aktina Corp.
11-215
In Commercial Distribution

  • B365112150 ()


  • Indexed-immobilization patient positioning system
No Description
Bion Enterprises, Ltd.
QEP-6604
In Commercial Distribution

  • B110QEP66040 ()
QEP-6604

  • Multiple enterovirus antigen IVD, control
mLife Verify 9 Panel Oral Fluid Drug Test AMP BAR BZO COC MDMA MET MTD OPI OXY
Mlife Diagnostics, LLC
MV002.09.0004EI
In Commercial Distribution

  • G474MV002090004EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FONA STELLARIS S1 SENSOR
SIRONA DENTAL, INC.
B1116200
In Commercial Distribution

  • D764B11162000 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005419
In Commercial Distribution

  • D7641000054191 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005412
In Commercial Distribution

  • D7641000054121 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005410
In Commercial Distribution

  • D7641000054101 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005392
In Commercial Distribution

  • D7641000053921 ()


  • Dental digital imaging sensor, intraoral
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