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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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Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor - 00817980020078

3 CH ECG Holter/ABP COMBINED Recorder
VASOMEDICAL, INC.
Model 2301
In Commercial Distribution

  • 00817980020078 ()
A10-0085

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder - 00817980020030

12 CH ECG Holter Ultra Recorder
VASOMEDICAL, INC.
Model 1308
In Commercial Distribution

  • 00817980020030 ()
A10-1308-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1304 12 Channel ECG Holter Recorder - 00817980020023

12 CH ECG Holter Recorder
VASOMEDICAL, INC.
Model 1304
In Commercial Distribution

  • 00817980020023 ()
A10-0082

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1307 Ultra Compact 3 Channel ECG Holter Recorder - 00817980020016

3 CH ECG Holter ULTRA Recorder
VASOMEDICAL, INC.
Model 1307
In Commercial Distribution

  • 00817980020016 ()
A10-1307-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1305 3 Channel ECG Holter Recorder - 00817980020009

3 CH ECG Holter Recorder
VASOMEDICAL, INC.
Model 1305
In Commercial Distribution

  • 00817980020009 ()
A10-0083

  • Electrocardiographic ambulatory recorder

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

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 - 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
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