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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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Health-Tec EarLoop Masks, Sensitive, White
Dental Health Products Inc
450-10001
In Commercial Distribution

  • D773450100013 ()
  • D773450100011 ()
  • D773450100010 ()
  • D773450100015 ()
450-10001

  • Surgical/medical respirator, non-antimicrobial, single-use
The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 235 cm.
SLATER ENDOSCOPY LLC
ES26235
In Commercial Distribution

  • M707ES26235 ()
  • M707ES262351 ()
  • M707ES262350 ()

  • Length: 235 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26235

  • Flexible endoscopic scissors, single-use
No Description
BIOTEX, INC.
SL-12
In Commercial Distribution

  • M710SL122 ()
  • M710SL120 ()
  • M710SL124 ()
SL-12

  • Operating room light
The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.
SLATER ENDOSCOPY LLC
ES26165
In Commercial Distribution

  • M707ES26165 ()
  • M707ES261651 ()
  • M707ES261650 ()

  • Length: 165 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26165

  • Flexible endoscopic scissors, single-use
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / OXY / MTD
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-39
In Commercial Distribution

  • M90107RD7065391 ()
  • M90107RD7065390 ()
  • M90107RD7065392 ()

  • Length: 75 Millimeter
07RD7065-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
IV START KIT
STRADIS MEDICAL LLC
IV-760
In Commercial Distribution

  • M752IV7600 ()
  • M765IV7605 ()
  • M752IV7605 ()


  • Peripheral intravenous catheterization support kit
Upper Extremity Drape
STRADIS MEDICAL, LLC
IN-9300CLF
Not in Commercial Distribution

  • M752IN9300CLF5 ()
  • M752IN9300CLF1 ()
  • M752IN9300CLF3 ()


  • Patient surgical drape, single-use
Dressing Change kit w/Sorbaview
STRADIS MEDICAL, LLC
IM1259
Not in Commercial Distribution

  • M752IM12595 ()
  • M752IM12590 ()
  • M752IM12596 ()


  • Wound dressing kit, medicated
Dressing Change Tray
STRADIS MEDICAL LLC
IM1256
In Commercial Distribution

  • M752IM12665 ()
  • M752IM12560 ()
  • M752IM12565 ()


  • Wound dressing kit, non-medicated
Dressing Change Tray W/ Biopatch
STRADIS MEDICAL, LLC
HCT9948BP
Not in Commercial Distribution

  • M752HCT9948BP5 ()
  • M752HCT9948BP0 ()
  • M752HCT9948BP6 ()


  • Wound dressing kit, medicated
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