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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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Soule Medical - 00810082220278

Medium/pediatric horseshoe - 5.5OD" x 2.25"ID x 1.25"H
SOULE CO., THE
RG2175
In Commercial Distribution

  • 00810082220278 ()
RG2175

  • Freestanding headrest, reusable

INOmax - 00810055280964

ADAPTER, 15M FITS 8.0 mm ID TUBING BCG, CE 2797
Mallinckrodt Manufacturing LLC
81096
In Commercial Distribution

  • 00810055280964 ()


  • Nitric oxide delivery unit, system-based

INOmax - 00810055283538

Adapter, 15M Fits 4.5 mm ID Tubing BCG, CE 2797
Mallinckrodt Manufacturing LLC
91353
In Commercial Distribution

  • 10810055283535 ()
  • 00810055283538 ()


  • Nitric oxide delivery unit, system-based

Blue Sky Bio, LLC - 00810060224151

BIO | Guide-Tube 7.2 OD x 6.26 ID x 3.5mm L
BLUE SKY BIO LLC
TUBE73-63-6L
In Commercial Distribution

  • 00810060224151 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060224137

Bio | Guide-Tube 7.2 OD x 6.2 ID x 3.5mm L
BLUE SKY BIO LLC
TUBE72-62-35L
In Commercial Distribution

  • 00810060224137 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060224076

Bio | Guide-Tube 6.0 OD x 5.0 ID x 3.5mm L
BLUE SKY BIO LLC
TUBE6-5-35L
In Commercial Distribution

  • 00810060224076 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060224069

BIO | Guide-Tube 6.0 OD x 5.06 ID x 3.5mm L
BLUE SKY BIO LLC
TUBE6-506-35L
In Commercial Distribution

  • 00810060224069 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060224052

Bio | Guide-Tube 6.35 OD x 5.35 ID x 4mm L
BLUE SKY BIO LLC
TUBE635-535-4L
In Commercial Distribution

  • 00810060224052 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060224045

Bio | Guide-Tube 6.25 OD x 5.25 ID x 4mm L
BLUE SKY BIO LLC
TUBE625-525-4L
In Commercial Distribution

  • 00810060224045 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060224014

Bio | Guide-Tube 6.15 OD x 5.15 ID x 4mm L
BLUE SKY BIO LLC
TUBE615-515-4L
In Commercial Distribution

  • 00810060224014 ()


  • Surgical torque wrench adaptor
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