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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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Neutrogena - 00070501101247

Light Therapy Acne Mask
Kenvue Brands LLC
00070501101247
Not in Commercial Distribution

  • 00070501101247 ()


  • Red/blue light phototherapy unit

C015 - 08053470960017

Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images
MICRONICA SRL
FP XL C015
In Commercial Distribution

  • 08053470960017 ()


  • Diagnostic x-ray digital imaging system workstation

C015 - 08053470960000

Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images
MICRONICA SRL
FP XS C015
In Commercial Distribution

  • 08053470960000 ()


  • Diagnostic x-ray digital imaging system workstation

H3+ - 00812345027112

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-BAD-XXXXX
In Commercial Distribution

  • 00812345027112 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345027105

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-BAA-XXXXX
In Commercial Distribution

  • 00812345027105 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345027099

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-AAC-XXXXX
Not in Commercial Distribution

  • 00812345027099 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345027044

Holter Recorder
MORTARA INSTRUMENT, INC.
BURH3PR
In Commercial Distribution

  • 00812345027044 ()


  • Electrocardiographic ambulatory recorder

medilogAR U - 07613365003765

The medilog®AR is used to record a 3-channel ECG. The recorder is designed for a measuring duration of more than 24 hours and is therefore worn by the patient throughout the day. The preparation for the recording (attachingelectrodes, etc.) is performed by the technician or doctor.
Schiller AG
1A.306010
In Commercial Distribution

  • 07613365003765 ()
  • 07613365003697 ()
1A.306010

  • Electrocardiographic ambulatory recorder

ER9W Cardiolabs - B146ERWCD040

No Description
BRAEMAR MANUFACTURING, LLC
900-0612-04
In Commercial Distribution

  • B146ERWCD040 ()


  • Electrocardiographic ambulatory recorder

ePatch - B146EP010

ePatch Holter Device
BRAEMAR MANUFACTURING, LLC
900-0630-00
In Commercial Distribution

  • B146EP010 ()


  • Electrocardiographic ambulatory recorder
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