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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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Apheresis Needle with MASTERGUARD Protector 17 Ga. x 1-1/4'' BE. Sterile Fluid Path.
FENWAL, INC.
4R2441
Not in Commercial Distribution

  • 10811137012418 ()
  • 00811137012411 ()
4R2441

  • Apheresis system tubing set
No Description
Biomet Orthopedics, LLC
31-473621
In Commercial Distribution

  • 00887868480911 ()
31-473621

  • Surgical mallet
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-07
In Commercial Distribution

  • 00810929014879 ()
  • 00810929014787 ()


  • Medical device cleaning agent
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-16
In Commercial Distribution

  • 00810929010345 ()
  • 00810929010338 ()


  • Medical device cleaning agent
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-13
In Commercial Distribution

  • 00810929010550 ()
  • 00810929010543 ()


  • Medical device cleaning agent
Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it. The holes in the conformer provide ventilation and act as an access point for eye drops.
Gulden Ophthalmics Inc.
14169
In Commercial Distribution

  • B091141691 ()
  • B091141690 ()

  • Width: 0.98 Inch
  • Length: 0.87 Inch
14169

  • Ophthalmic conformer
Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it. The holes in the conformer provide ventilation and act as an access point for eye drops.
Gulden Ophthalmics Inc.
14168
In Commercial Distribution

  • B091141681 ()
  • B091141680 ()

  • Width: 0.94 Inch
  • Length: 0.83 Inch
14168

  • Ophthalmic conformer
Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it. The holes in the conformer provide ventilation and act as an access point for eye drops.
Gulden Ophthalmics Inc.
14167
In Commercial Distribution

  • B091141671 ()
  • B091141670 ()

  • Width: 0.87 Inch
  • Length: 0.75 Inch
14167

  • Ophthalmic conformer
The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.
Sanuwave, Inc.
DEP0330/DAP0332
In Commercial Distribution

  • 00812265010225 ()


  • Dermatological extracorporeal shock wave therapy system
Modified HTF Medium with Human Serum Albumin (HSA). 100mL bottle.
IRVINE SCIENTIFIC, LLC
9983-100ML
In Commercial Distribution

  • 00810195240170 ()
9983

  • IVF medium
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