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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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VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE EXTRA SMALL
OBP CORPORATION
C020130-1
In Commercial Distribution

  • M648C02013012 ()
  • M648C02013011 ()
  • M648C02013010 ()


  • Vaginal speculum, single-use
VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE
OBP CORPORATION
C020120-1
In Commercial Distribution

  • M648C02012012 ()
  • M648C02012011 ()
  • M648C02012010 ()
C020120-1

  • Vaginal speculum, single-use
VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE MEDIUM
OBP CORPORATION
C020110-1
In Commercial Distribution

  • M648C02011012 ()
  • M648C02011011 ()
  • M648C02011010 ()
C020110-1

  • Vaginal speculum, single-use
VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL
OBP CORPORATION
C020100-1
In Commercial Distribution

  • M648C02010012 ()
  • M648C02010011 ()
  • M648C02010010 ()
C020100-1

  • Vaginal speculum, single-use
SINGLE-SIDED VAGINAL SPECULUM WITH LIGHT SINGLE-USE SIZE MEDIUM
OBP CORPORATION
C020001
In Commercial Distribution

  • M648C0200012 ()
  • M648C0200011 ()
  • M648C0200010 ()
C020001

  • Vaginal speculum, single-use
TracLux SLS-S, Battery Operated Lightsource
SUNOPTIC TECHNOLOGIES LLC
TracLux-SLS
In Commercial Distribution

  • M678TLCSLS0 ()
  • M678TLCSLS1 ()
  • M678TLCSLS3 ()
TLC1353-SLSU

  • Open surgical site internal light
TRACLUX Light Carrier, Sterile, Single Use, and accessories
SUNOPTIC TECHNOLOGIES LLC
TLC
In Commercial Distribution

  • M678TLC0 ()
  • M678TLC1 ()
  • M678TLC3 ()
TLC2575, TLC25150, TLC1353-U

  • Open surgical site internal light
Battery powered light source for illumination of a surgical field.
SUNOPTIC TECHNOLOGIES LLC
ROVER SLS
In Commercial Distribution

  • M678SLSS0 ()
  • M678SLSS1 ()
  • M678SLSS3 ()
ROVER SLS-S

  • Open surgical site internal light
The ResQCPR system contains two ResQPODs and one ResQPump
ADVANCED CIRCULATORY SYSTEMS INC
12-0825-000
In Commercial Distribution

  • M5921208220000 ()
  • M5921208250001 ()
  • M5921208230001 ()


  • Cardiac resuscitator, manual
The ResQPOD ITD 10 is indicated for the temporary increase in blood circulation.
ADVANCED CIRCULATORY SYSTEMS INC
12-0242-000
In Commercial Distribution

  • M5921202420000 ()
  • M5921202420001 ()
  • M5921202420002 ()


  • Cardiopulmonary resuscitation impedance valve, inspiratory
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