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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Assy, ZOLL AED 3 Aviation Battery Pack, FDK
Zoll Medical Corporation
1028-000003
In Commercial Distribution

  • 00847946026745 ()


  • Disposable battery pack
Lithium sulfur dioxide battery for use with Cardiac Science(TM) G5 models G5A-80A, G5A-80C, G5S-80A, G5S-80C
AED BATTERY EXCHANGE, LLC
G5-ABE
In Commercial Distribution

  • 00864312000284 ()


  • Disposable battery pack
Lithium Manganese Dioxide battery for use in Philips(TM) HeartStart(TM) FR3 AED's 861388 and 861389
AED BATTERY EXCHANGE, LLC
FR3-ABE
In Commercial Distribution

  • 00864312000277 ()


  • Disposable battery pack
FREEDOM BTE RECHARGEABLE BATTERY, BROWN
COCHLEAR LIMITED
Z61021
In Commercial Distribution

  • 09321502029247 ()
Z61021

  • Secondary battery
  • Portable/mobile rechargeable battery pack
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-004
In Commercial Distribution

80008-004

  • Wearable defibrillation system defibrillator
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-003
In Commercial Distribution

  • 00840241600030 ()
80008-003

  • Wearable defibrillation system defibrillator
SMARTLOAD TECNIS EYHANCE US IOL 34.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830158 ()

  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:34.00 DIO
GIB00U0340

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 33.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830141 ()

  • OPTICAL POWER:33.50 DIO
  • Outer Diameter: 13.00 Millimeter
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0335

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 33.0D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830134 ()

  • OPTICAL POWER:33.00 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
  • Outer Diameter: 13.00 Millimeter
GIB00U0330

  • Posterior-chamber intraocular lens, pseudophakic
SMARTLOAD TECNIS EYHANCE US IOL 32.5D
JOHNSON & JOHNSON SURGICAL VISION, INC.
GIB00
In Commercial Distribution

  • 05050474830127 ()

  • Outer Diameter: 13.00 Millimeter
  • OPTICAL POWER:32.50 DIO
  • OPTICAL ZONE DIAMETER:6.00 mm
GIB00U0325

  • Posterior-chamber intraocular lens, pseudophakic
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