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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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SYNCHRO 2 - 04546540688729

Soft Guidewire with Hydrophilic Coating
Stryker Corporation
M00326010
In Commercial Distribution

  • 04546540688729 ()

  • Outer Diameter: 0.014 Inch
  • Length: 200.0 Centimeter
2601

  • Cardiac/peripheral vascular guidewire, single-use

Pursuit 2 - 00606509300643

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
Pursuit 2
In Commercial Distribution

  • 00606509300643 ()
N/A

  • Assistive scooter, electric-motor-driven

Actiwatch 2 - 00606959003903

Actiwatch 2 Communication Dock System
Respironics, Inc.
Actiwatch 2 Communication Dock System
In Commercial Distribution

  • 00606959003903 ()
1048092

  • Kinesiology ambulatory recorder

Actiwatch 2 - 00606959003897

Actiwatch 2 Device
Respironics, Inc.
Actiwatch 2 Device
In Commercial Distribution

  • 00606959003897 ()
1048090

  • Kinesiology ambulatory recorder

Actiwatch 2 - 00606959003842

Actiwatch 2 System
Respironics, Inc.
Actiwatch 2 System
In Commercial Distribution

  • 00606959003842 ()
1044809

  • Kinesiology ambulatory recorder

Q4 2 - 00606509200264

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Pride Mobility Products Corp
Q4 2
In Commercial Distribution

  • 00606509200264 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

Actiwatch 2 - 00606959043862

Actiwatch 2 Dock Sub Assembly
Respironics, Inc.
Actiwatch 2 Dock Sub Assembly
In Commercial Distribution

  • 00606959043862 ()
1047045

  • Kinesiology ambulatory recorder

ACTIWATCH 2 - 00606959043855

Actiwatch 2 Device
Respironics, Inc.
Actiwatch 2 Device
In Commercial Distribution

  • 00606959043855 ()
1043633

  • Kinesiology ambulatory recorder

COMFORTFULL 2 - 00606959041837

COMFORTFULL 2 MASK with STANDARD ELBOW, LARGE, CHINA
Respironics, Inc.
COMFORTFULL 2 MASK with SE, LARGE, CHINA
Not in Commercial Distribution

  • 00606959041837 ()
CN1024262

  • CPAP/BPAP face mask, reusable

COMFORTFULL 2 - 00606959041820

COMFORTFULL 2 MASK with Standard Elbow, MEDIUM, CHINA
Respironics, Inc.
COMFORTFULL 2 MASK with SE, MEDIUM, CHINA
Not in Commercial Distribution

  • 00606959041820 ()
CN1024261

  • CPAP/BPAP face mask, reusable
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