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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 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
Disposable Stethoscope
GF HEALTH PRODUCTS, INC.
722Y
In Commercial Distribution

  • M368722Y2 ()
  • M368722Y1 ()
  • M368722Y3 ()


  • Mechanical stethoscope
Disposable Stethoscope
GF HEALTH PRODUCTS, INC.
722B
In Commercial Distribution

  • M368722B2 ()
  • M368722B1 ()
  • M368722B3 ()


  • Mechanical stethoscope
Portable Ultrasonic Nebulizer
GF HEALTH PRODUCTS, INC.
6700
In Commercial Distribution

  • M36867003 ()
  • M36867002 ()
  • M36867001 ()


  • Benchtop nebulizer, non-heated
TENS Electrodes
GF HEALTH PRODUCTS, INC.
9261
In Commercial Distribution

  • M36892613 ()
  • M36892612 ()
  • M36892611 ()


  • Transcutaneous electrical stimulation electrode, single-use
TENS Electrodes
GF HEALTH PRODUCTS, INC.
9260
In Commercial Distribution

  • M36892603 ()
  • M36892602 ()
  • M36892601 ()
  • M36892600 ()


  • Transcutaneous electrical stimulation electrode, single-use
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