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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™ 1200 ECG Holter Mini Recorder - 00817980020344

1200 ECG Holter Mini Recorder
VASOMEDICAL, INC.
Model 1200
In Commercial Distribution

  • 00817980020344 ()
A10-1200-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder - 00817980020184

12 CH ECG Holter ULTRA Recorder
VASOMEDICAL, INC.
Model 1306
In Commercial Distribution

  • 00817980020184 ()
A10-1306-01

  • Electrocardiographic ambulatory recorder

H12+ - 00817655022932

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

  • 00817655022932 ()


  • Electrocardiographic ambulatory recorder

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

Sonoma Orthopedic Products, Inc - 00816988010326

3.5mm Syndesmotic Drill, Non-sterile
ARTHREX, INC.
IN0066
Not in Commercial Distribution

  • 00816988010326 ()
IN0066

  • Patient monitoring system module, printing

Konica Minolta SW (PACS) Exa - 00817100020193

EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
EXA 01-04-000
In Commercial Distribution

  • 00817100020193 ()


  • Diagnostic x-ray digital imaging system workstation

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020490

Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-06-000
In Commercial Distribution

  • 00817100020490 ()


  • Diagnostic x-ray digital imaging system workstation
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