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
5CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT5CC-LL
In Commercial Distribution

  • M752HCT5CCLL0 ()
  • M752HCT5CCLL5 ()
  • M752HCT5CCLL1 ()


  • General-purpose syringe, single-use
Dressing Change Tray
STRADIS MEDICAL, LLC
HCT5040CHG
In Commercial Distribution

  • M752HCT5040CHG5 ()
  • M752HCT5040CHG0 ()
  • M752HCT5040CHG6 ()


  • Wound dressing kit, medicated
3CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT3CC-LL
In Commercial Distribution

  • M752HCT3CCLL5 ()
  • M752HCT3CCLL0 ()
  • M752HCT3CCLL1 ()


  • General-purpose syringe, single-use
6CC SYRINGE KIT
STRADIS MEDICAL LLC
HCT3916-1
In Commercial Distribution

  • M752HCT391612 ()
  • M752HCT391611 ()
  • M752HCT391615 ()
  • M752HCT391610 ()


  • General-purpose syringe, single-use
6CC SYRINGE KIT
STRADIS MEDICAL LLC
HCT3916
In Commercial Distribution

  • M752HCT39161 ()
  • M752HCT39162 ()
  • M752HCT39165 ()
  • M752HCT39160 ()


  • General-purpose syringe, single-use
12CC SYRINGE KIT
STRADIS MEDICAL LLC
HCT3548-2
In Commercial Distribution

  • M752HCT354822 ()
  • M752HCT354821 ()
  • M752HCT354825 ()
  • M752HCT354820 ()


  • General-purpose syringe, single-use
12CC SYRINGE KIT
STRADIS MEDICAL LLC
HCT3548
In Commercial Distribution

  • M752HCT35485 ()
  • M752HCT35482 ()
  • M752HCT35481 ()
  • M752HCT35480 ()


  • General-purpose syringe, single-use
1CC SLIP TIP SYRINGES
STRADIS MEDICAL LLC
HCT1CC-ST
In Commercial Distribution

  • M752HCT1CCST5 ()
  • M752HCT1CCST0 ()
  • M752HCT1CCST1 ()


  • General-purpose syringe, single-use
1CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT1CC-LL
In Commercial Distribution

  • M752HCT1CCLL5 ()
  • M752HCT1CCLL0 ()
  • M752HCT1CCLL1 ()


  • General-purpose syringe, single-use
10CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT10CC-LL
In Commercial Distribution

  • M752HCT10CCLL5 ()
  • M752HCT10CCLL1 ()
  • M752HCT10CCLL0 ()


  • General-purpose syringe, single-use
Catheter Securement Device
STRADIS MEDICAL LLC
CPD-2000
In Commercial Distribution

  • M752CPD20003 ()
  • M752CPD20000 ()
  • M752CPD20005 ()


  • Wearable percutaneous catheter/tube holder
SYRINGE CONVENIENCE PACK-1CC L/L
STRADIS MEDICAL LLC
TM.SCP1ML
In Commercial Distribution

  • M752TMSCP1ML5 ()
  • M752TMSCP1ML0 ()
  • M752TMSCP1ML1 ()


  • General-purpose syringe, single-use
FLUID FILTER TRANSFER KIT
STRADIS MEDICAL LLC
TM.FFTK
In Commercial Distribution

  • M752TMFFTK5 ()
  • M752TMFFTK0 ()
  • M752TMFFTK1 ()


  • Fluid transfer set, general-purpose
TracLux SLS-S, Battery Operated Lightsource
SUNOPTIC TECHNOLOGIES LLC
TracLux-SLS
In Commercial Distribution

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

  • Open surgical site internal light
Closed Wound Drain, Round, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803641
In Commercial Distribution

  • M6658036413 ()
  • M6658036411 ()
  • M6658036410 ()

  • 12 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803640AT
In Commercial Distribution

  • M665803640AT3 ()
  • M665803640AT1 ()
  • M665803640AT0 ()

  • 7 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803631AT
In Commercial Distribution

  • M665803631AT3 ()
  • M665803631AT1 ()
  • M665803631AT0 ()

  • 7 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803631
In Commercial Distribution

  • M6658036313 ()
  • M6658036311 ()
  • M6658036310 ()

  • 7 mm


  • Closed-wound drain, non-bioabsorbable
Thoracic Catheter, Straight, PVC, With Trocar
AXIOM MEDICAL, INCORPORATED
522216
In Commercial Distribution

  • M6655222163 ()
  • M6655222161 ()
  • M6655222160 ()

  • 16 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC, With Trocar
AXIOM MEDICAL, INCORPORATED
522212
In Commercial Distribution

  • M6655222123 ()
  • M6655222121 ()
  • M6655222120 ()

  • 12 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC, With Trocar
AXIOM MEDICAL, INCORPORATED
522210
In Commercial Distribution

  • M6655222103 ()
  • M6655222101 ()
  • M6655222100 ()

  • 10 FR


  • Pleural catheter
Thoracic Catheter, Right Angle PVC
AXIOM MEDICAL, INCORPORATED
522208
In Commercial Distribution

  • M6655222083 ()
  • M6655222081 ()
  • M6655222080 ()

  • 8 FR


  • Pleural catheter
Thoracic Catheter, Right Angle PVC
AXIOM MEDICAL, INCORPORATED
511132
In Commercial Distribution

  • M6655111323 ()
  • M6655111321 ()
  • M6655111320 ()

  • 32 FR


  • Pleural catheter
Thoracic Catheter, Right Angle PVC
AXIOM MEDICAL, INCORPORATED
511124
In Commercial Distribution

  • M6655111243 ()
  • M6655111241 ()
  • M6655111240 ()

  • 24 FR


  • Pleural catheter
Thoracic Catheter, Right Angle PVC
AXIOM MEDICAL, INCORPORATED
511016
In Commercial Distribution

  • M6655110163 ()
  • M6655110161 ()
  • M6655110160 ()

  • 16 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500040
In Commercial Distribution

  • M6655000403 ()
  • M6655000401 ()
  • M6655000400 ()

  • 40 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500032
In Commercial Distribution

  • M6655000323 ()
  • M6655000321 ()
  • M6655000320 ()

  • 32 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500028
In Commercial Distribution

  • M6655000283 ()
  • M6655000281 ()
  • M6655000280 ()

  • 28 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500024
In Commercial Distribution

  • M6655000243 ()
  • M6655000241 ()
  • M6655000240 ()

  • 24 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500016
In Commercial Distribution

  • M6655000163 ()
  • M6655000161 ()
  • M6655000160 ()

  • 16 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500014
In Commercial Distribution

  • M6655000143 ()
  • M6655000141 ()
  • M6655000140 ()

  • 14 FR


  • Pleural catheter
Closed Wound Facial Drains (Two), Flat, Silicone, With Bifurcated Connector, With ClotStop®
AXIOM MEDICAL, INCORPORATED
412AT
In Commercial Distribution

  • M665412AT3 ()
  • M665412AT1 ()
  • M665412AT0 ()

  • 4 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
410AT
In Commercial Distribution

  • M665410AT3 ()
  • M665410AT1 ()
  • M665410AT0 ()

  • 4 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
401AT
In Commercial Distribution

  • M665401AT3 ()
  • M665401AT1 ()
  • M665401AT0 ()

  • Length: 16 Inch
  • 10 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3642AT
In Commercial Distribution

  • M6653642AT3 ()
  • M6653642AT1 ()
  • M6653642AT0 ()

  • 10 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone
AXIOM MEDICAL, INCORPORATED
3641
In Commercial Distribution

  • M66536413 ()
  • M66536411 ()
  • M66536410 ()

  • 12 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3640AT
In Commercial Distribution

  • M6653640AT3 ()
  • M6653640AT1 ()
  • M6653640AT0 ()

  • 7 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3631AT
In Commercial Distribution

  • M6653631AT3 ()
  • M6653631AT1 ()
  • M6653631AT0 ()

  • 7 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3626AT
In Commercial Distribution

  • M6653626AT3 ()
  • M6653626AT1 ()
  • M6653626AT0 ()

  • 10 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Reservoir, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3603AT
In Commercial Distribution

  • M6653603AT3 ()
  • M6653603AT1 ()
  • M6653603AT0 ()

  • 13 mm
  • Total Volume: 150 Milliliter


  • Closed-wound drain, non-bioabsorbable
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