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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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10G, 15mm One Balloon Kit/Dual Access
Zavation LLC
VCF-1015-1RX
In Commercial Distribution

  • 00197157004996 ()


  • Balloon kyphoplasty kit
10G, 20mm One Balloon Kit/Dual Access-AFX
Zavation LLC
VCF-1020-1ARX
In Commercial Distribution

  • 00197157005030 ()


  • Balloon kyphoplasty kit
10G, 10mm One Balloon Kit/Dual Access
Zavation LLC
VCF-1010-1RX
In Commercial Distribution

  • 00197157005016 ()


  • Balloon kyphoplasty kit
10G, 10mm One Balloon Kit/Dual Access
Zavation LLC
VCF-1010-1RX
In Commercial Distribution

  • 00197157004989 ()


  • Balloon kyphoplasty kit
FHC-102H Dollar General Preg One Step Cassette
DOLGENCORP, LLC
FHC-102H
Not in Commercial Distribution

  • 00430000702077 ()
  • 10430000702074 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
REMstar Plus, System One 60 Series, Canada
Respironics, Inc.
REMstar Plus, 60 Series, CA
In Commercial Distribution

  • 00606959030053 ()
CA261S

  • Home CPAP unit
A Series System One Heated Humidifier, US
Respironics, Inc.
A Series System One Heated Humidifier, US
In Commercial Distribution

  • 00606959039629 ()
1111551

  • Heated respiratory humidifier
A Series, System One Heated Humidifier, USA
Respironics, Inc.
A Series System One Heated Humidifier, US
In Commercial Distribution

  • 00606959032071 ()
1111513

  • Heated respiratory humidifier
BiPAP A Series, System One Humidifier, Japan
Respironics, Inc.
BiPAP A Series, System One Humidifier, JP
Not in Commercial Distribution

  • 00606959032057 ()
1111515

  • Heated respiratory humidifier
A Series System One Heated Humidifier, International
Respironics, Inc.
A Series, System One, Heated Humidifier, INTL
In Commercial Distribution

  • 00606959032026 ()
1111517

  • Heated respiratory humidifier
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