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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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IMAGE DIAGNOSTICS INC - 00850977007454

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 32IN. MONITOR,FIXED,ILEX32,#A280-0630 OR #A280-0821 FOR THE 4K VERSION
IMAGE DIAGNOSTICS, INC.
ilex32
In Commercial Distribution

  • 00850977007454 ()
A280-0630 & A280-0821

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007447

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/IPS500A,230V,#A280-0781
IMAGE DIAGNOSTICS, INC.
ilex55, 230V
In Commercial Distribution

  • 00850977007447 ()
A280-0781

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007430

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/IPS500A,120V,#A280-0600 OR W/IPS1000A #A280-0700
IMAGE DIAGNOSTICS, INC.
ilex55, 120V
In Commercial Distribution

  • 00850977007430 ()
A280-0600 OR A280-0700

  • Diagnostic x-ray digital imaging system workstation

Microlife - 04719003932053

No Description
MICROLIFE USA, INC.
CUFFM-WBPOANKLE
In Commercial Distribution

  • 14719003932050 ()
  • 04719003932053 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 04719003631284

No Description
MICROLIFE USA, INC.
BP3SZ1-1AFIB
In Commercial Distribution

  • 14719003631281 ()
  • 04719003631284 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 04719003315085

WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets
MICROLIFE USA, INC.
CRO-BP3MX1-3C1
In Commercial Distribution

  • 04719003315085 ()
  • 14719003315082 ()
  • 24719003315089 ()
  • 34719003315086 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 04719003315047

WatchBP O3 2G(BP3SZ1-1) CBP type
MICROLIFE USA, INC.
BP3SZ1-1CEN
In Commercial Distribution

  • 14719003315044 ()
  • 04719003315047 ()
  • 24719003315041 ()
WatchBP O3 2G

  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 04719003315030

WatchBP O3 2G(BP3SZ1-1) Advanced type
MICROLIFE USA, INC.
BP3SZ1-1
In Commercial Distribution

  • 14719003315037 ()
  • 04719003315030 ()
  • 24719003315034 ()
WatchBP O3 2G

  • Arrythmia-detection blood pressure ambulatory recorder

Shark - 00622356086912

The CryoGlow is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
SharkNinja Operating LLC
CryoGlow
In Commercial Distribution

  • 00622356086912 ()


  • Red/blue light phototherapy unit

n/a - 04961333231614

REMOVABLE HARD DRIVES FOR 7245C
PENTAX OF AMERICA, INC.
7202B
In Commercial Distribution

  • 04961333231614 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231386

DIGITAL SWALLOWING CABLE
PENTAX OF AMERICA, INC.
7184-5900
In Commercial Distribution

  • 04961333231386 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231362

THREE BULB ARRAY
PENTAX OF AMERICA, INC.
7181-9900
In Commercial Distribution

  • 04961333231362 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231355

TWO BULB ARRAY
PENTAX OF AMERICA, INC.
7181-9800
In Commercial Distribution

  • 04961333231355 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231348

EMG CABLE,6' (1250-0334)
PENTAX OF AMERICA, INC.
7180-2102
In Commercial Distribution

  • 04961333231348 ()

  • Length: 6.0 Feet


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231317

SYNC MODULE FOR PAL 230V
PENTAX OF AMERICA, INC.
7127E
Not in Commercial Distribution

  • 04961333231317 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231300

SWALLOWING UPGRADE
PENTAX OF AMERICA, INC.
7120B-2
Not in Commercial Distribution

  • 04961333231300 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231171

MONITOR, ACER V196L 19" LCD
PENTAX OF AMERICA, INC.
1111-1420
In Commercial Distribution

  • 04961333231171 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231331

EMG CABLE,6' (1250-0335)
PENTAX OF AMERICA, INC.
7180-2101
In Commercial Distribution

  • 04961333231331 ()

  • Length: 6.0 Feet


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231188

ANALOG-DIGITAL CONVERT DFG/SV1
PENTAX OF AMERICA, INC.
1111-1582
In Commercial Distribution

  • 04961333231188 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231089

SYNC MODULE FOR FULL SYSTEM
PENTAX OF AMERICA, INC.
7127
Not in Commercial Distribution

  • 04961333231089 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231072

TONGUE HARDWARE W/25 ARRAYS
PENTAX OF AMERICA, INC.
7124
In Commercial Distribution

  • 04961333231072 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230495

Tongue Arrays
PENTAX OF AMERICA, INC.
7183-4500
In Commercial Distribution

  • 04961333230495 ()
  • 34961333230496 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230464

Tongue Arrays
PENTAX OF AMERICA, INC.
7179-0040
In Commercial Distribution

  • 04961333230464 ()
  • 34961333230465 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333230457

Tongue Arrays
PENTAX OF AMERICA, INC.
7179-0035
In Commercial Distribution

  • 04961333230457 ()
  • 34961333230458 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333230440

Nasal Cannulas
PENTAX OF AMERICA, INC.
7179-0030
In Commercial Distribution

  • 04961333230440 ()
  • 14961333230446 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230433

Electrodes
PENTAX OF AMERICA, INC.
7179-0025
In Commercial Distribution

  • 04961333230433 ()
  • 14961333230439 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230426

Electrodes
PENTAX OF AMERICA, INC.
7179-0020
In Commercial Distribution

  • 04961333230426 ()
  • 14961333230422 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333229956

Laryngeal Microphone
PENTAX OF AMERICA, INC.
7126
In Commercial Distribution

  • 04961333229956 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333229949

Nasal Cannulas
PENTAX OF AMERICA, INC.
7125
In Commercial Distribution

  • 04961333229949 ()
  • 14961333229945 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333229932

Manometry Sensors (Gaeltec)
PENTAX OF AMERICA, INC.
7123
In Commercial Distribution

  • 04961333229932 ()


  • Manometric gastrointestinal motility analysis system
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