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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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Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
PREL1XX
Not in Commercial Distribution

  • 00850013007011 ()
PREL1XX

  • Tympanic membrane contact hearing aid sound processor
Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.
SONIVATE MEDICAL, INC.
SDA-001
In Commercial Distribution

  • 00850012978015 ()


  • Hand-held ultrasound imaging system, body-surface
Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.
SONIVATE MEDICAL, INC.
SDA-001
In Commercial Distribution

  • 00850012978008 ()


  • Hand-held ultrasound imaging system, body-surface
Color-coded disposable LED laryngoscope blade (Miller 4 - Lime)
Hartwell Medical LLC
LB 51MIL4-DS
In Commercial Distribution

  • 10850012936920 ()
  • 00850012936923 ()

  • Miller 4
LB 51MIL4-DS

  • Laryngoscope blade, single-use
Disposable laryngoscope blade (Adult)
Hartwell Medical LLC
GV 2020A-DS
In Commercial Distribution

  • 10850012936692 ()
  • 00850012936695 ()

  • Adult
GV 2020A-DS

  • Laryngoscope blade, single-use
Standard laryngoscope handle (medium)
Hartwell Medical LLC
GV 1002
In Commercial Distribution

  • 00850012936664 ()

  • Medium
GV 1002

  • Laryngoscope handle, reusable
Standard laryngoscope handle (small)
Hartwell Medical LLC
GV 1001
In Commercial Distribution

  • 00850012936657 ()

  • Small
GV 1001

  • Laryngoscope handle, reusable
Color-coded disposable LED laryngoscope blade (Miller 3 - Orange)
Hartwell Medical LLC
LB 51MIL3-DS
In Commercial Distribution

  • 10850012936098 ()
  • 00850012936091 ()

  • Miller 3
LB 51MIL3-DS

  • Laryngoscope blade, single-use
Color-coded disposable LED laryngoscope blade (Miller 2 - Yellow)
Hartwell Medical LLC
LB 51MIL2-DS
In Commercial Distribution

  • 10850012936081 ()
  • 00850012936084 ()

  • Miller 2
LB 51MIL2-DS

  • Laryngoscope blade, single-use
Color-coded disposable LED laryngoscope blade (Miller 1 - Pink)
Hartwell Medical LLC
LB 51MIL1-DS
In Commercial Distribution

  • 10850012936074 ()
  • 00850012936077 ()
LB 51MIL1-DS

  • Laryngoscope blade, single-use
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