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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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HAWK - 08800017900025

Highest resolution 1280 x 720 delivers precise, true-to-life images auto-focus system 15 advanced LED lights for the correct color representation
DXM CO., LTD
HD
In Commercial Distribution

  • 08800017900025 ()


  • Intraoral camera

ABP - 10841522107719

LOANER - ABP ONTRAK MONITOR, MULTI-LINGUAL
SPACELABS HEALTHCARE (WASHINGTON), INC
90227
Not in Commercial Distribution

  • 10841522107719 ()
L-90227-1

  • Blood pressure ambulatory recorder

Spacelabs Healthcare - 10841522106675

Blood Pressure Long-Term Ambulatory Recorder
SPACELABS HEALTHCARE (WASHINGTON), INC
90207
Not in Commercial Distribution

  • 10841522106675 ()
N/A

  • Blood pressure ambulatory recorder

ABP - 10841522105074

Ambulatory Blood Pressure Monitor
SPACELABS HEALTHCARE (WASHINGTON), INC
90217
Not in Commercial Distribution

  • 10841522105074 ()
N/A

  • Blood pressure ambulatory recorder

Ultralite - 10841522105067

ABP ULTRALITE MONITOR,MULTI-LINGUAL
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultralite
In Commercial Distribution

  • 10841522105067 ()
90217A-1

  • Blood pressure ambulatory recorder

OnTrak - 10841522131431

ABP ONTRAK MONITOR, BRAZIL, 90227
SPACELABS HEALTHCARE (WASHINGTON), INC
OnTrak
In Commercial Distribution

  • 10841522131431 ()
90227-8

  • Blood pressure ambulatory recorder

Ontrak - 10841522129629

CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129629 ()

  • 38-50 cm OD
  • 15-20 in OD
016-0109-06Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129612

CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129612 ()

  • 32-42 cm OD
  • 13-17 in OD
016-0077-07Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129605

CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129605 ()

  • 12-20 cm OD
  • 5-8 in. OD
015-0118-06Q

  • Blood pressure ambulatory recorder

Spacelabs - 10841522129599

CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129599 ()
015-0068-07Q

  • Blood pressure ambulatory recorder
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