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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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Sentinel - 10841522103117

SENTINEL 10 WORKSTATION (X5) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103117 ()
040-1711-00

  • Cardiology information system application software

Sentinel - 10841522103100

SENTINEL 10 WORKSTATION (X2) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103100 ()
040-1710-00

  • Cardiology information system application software

Sentinel - 10841522103094

SENTINEL 10 WORKSTATION (X1) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103094 ()
040-1709-00

  • Cardiology information system application software

Critical Care Suite - 00195278789365

Critical Care Suite 2.1, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00195278789365 ()


  • X-ray image interpretive software

SphygmoCor - 19351315000017

Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others]. CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL: • CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)] • CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
ATCOR MEDICAL PTY LTD
CVMS
In Commercial Distribution

  • 19351315000017 ()
  • 19351315000024 ()


  • Patient monitoring system module, multifunction

Endowrist SP - 00886874122228

CAMERA, 0°
INTUITIVE SURGICAL, INC.
430077
In Commercial Distribution

  • 00886874122228 ()

  • Outer Diameter: 6 Millimeter


  • Rigid optical laparoscope

Wireless Programming Pod CP1000 - 09321502038164

CP1000
COCHLEAR LIMITED
Z597944
In Commercial Distribution

  • 09321502038164 ()
Z597944

  • Hearing aid/implant system programming interface unit

Nucleus - 09321502009584

Cochlear Nucleus Freedom Programming POD
COCHLEAR LIMITED
Z60686
In Commercial Distribution

  • 09321502009584 ()
Z60686

  • Hearing aid/implant system programming interface unit

Wireless Programming Pod CP800 Series CP900 Series - 09321502034401

N/A
COCHLEAR LIMITED
Z594046
In Commercial Distribution

  • 09321502034401 ()
Z594046

  • Hearing aid/implant system programming interface unit

Earlens Wireless Programmer - 00850013007110

Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit
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