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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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Holter Prep Kit - 10812345026020

Holter prep kit with AAA battery cleared with H3+ Holter recorder
MORTARA INSTRUMENT, INC.
XKTHOLT5LA
Not in Commercial Distribution

  • 30812345026024 ()
  • 20812345026027 ()
  • 10812345026020 ()


  • Electrocardiographic ambulatory recorder

SOLAR Compact - 08720648846052

SOLAR Compact
Laborie Medical Technologies Corp.
G4-1
In Commercial Distribution

  • 08720648846052 ()


  • Manometric gastrointestinal motility analysis system

Solar GI air-charged 4P, Compact Pole system - 08720648846007

Solar GI air-charged 4P, Compact Pole system, 115V
Medical Measurement Systems B.V.
G3-7 Air
In Commercial Distribution

  • 08720648846007 ()


  • Manometric gastrointestinal motility analysis system

DemarkQ - 08720299044227

The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Light Tree Ventures Europe B.V.
P19-0007
In Commercial Distribution

  • 08720299044227 ()


  • Red/blue light phototherapy unit

7LS - 00031262096265

ReNew Light Therapy
FKA DISTRIBUTING CO., LLC
FA7-1450J
In Commercial Distribution

  • 00031262096265 ()
FA7-1450J

  • Red/blue light phototherapy unit

SICAT Function - D77664556410

Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation

SICAT Suite - D77664556330

No Description
SiCAT GmbH & Co. KG
6455633
Not in Commercial Distribution

  • D77664556330 ()
6455633

  • Diagnostic x-ray digital imaging system workstation

Nuubo System - 08437011759078

NuuboREC Box USA. Ambulatory ECG monitoring device (Holter) up to 30 days.
SMART SOLUTIONS TECHNOLOGIES SL
2140
In Commercial Distribution

  • 08437011759078 ()
2140

  • Electrocardiographic ambulatory recorder

SEER - 00840682116886

SEER 1000 PC APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 PC Application
In Commercial Distribution

  • 00840682116886 ()


  • Electrocardiographic ambulatory recorder

SEER - 00840682116879

SEER 1000 IOS APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 IOS Application
In Commercial Distribution

  • 00840682116879 ()


  • Electrocardiographic ambulatory recorder
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