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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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ELEOS™ MODULAR TIBIAL BASE STEM CAP ONE SIZE
ONKOS SURGICAL, INC.
KSC01500E
In Commercial Distribution

  • B278KSC01500E0 ()
KSC01500E

  • Knee femur stem prosthesis
One Material Thousand Shades - Light Cure Flowable Restorative Composite
First Scientific Dental Materials GmbH
11-004
In Commercial Distribution

  • E11004 ()
  • EFSM110040 ()


  • Dental composite resin
Eight single-use tubes of Eroxon gel in one carton.
Haleon US Holdings LLC
Eight Pack
In Commercial Distribution

  • 00307663075896 ()
  • 00307663076091 ()


  • Penile cooling/warming gel
Four single-use tubes of Eroxon gel in one carton.
Haleon US Holdings LLC
Four Pack
In Commercial Distribution

  • 00307663074806 ()
  • 00307663075896 ()


  • Penile cooling/warming gel
1.8mm Draw Tight Suture Anchor with One Suture Tape
PARCUS MEDICAL LLC
11148
In Commercial Distribution

  • M685111480 ()
11148

  • Tendon/ligament bone anchor, non-bioabsorbable
System One Heated Humidifier, A40 ProEFL, Intl Core Pack
Respironics, Inc.
INX3HCP
In Commercial Distribution

  • 00606959058750 ()
INX3HCP

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Tube Humidifier, United Kingdom
Respironics, Inc.
GBX3T
In Commercial Distribution

  • 00606959058491 ()
GBX3T

  • Heated respiratory humidifier
REMstar Auto C-Flex+, BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto A-Flex, with BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959030558 ()
CA561BT

  • Home CPAP unit
REMstar Pro C-Flex+, System One 60 Series, Latin America
Respironics, Inc.
REMstar Pro C-Flex+ System One 60 Series LA
Not in Commercial Distribution

  • 00606959030282 ()
LA461S

  • Home CPAP unit
REMstar Pro C-Flex+, BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Pro C-Flex+, with BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959030176 ()
CA461BT

  • Home CPAP unit
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