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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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C-Thru - 00810045920320

C-Thru Adult Armboard, 11" Long one end x 25" Long on other x 11" Wide
INSTRUMENT SPECIALISTS, INC.
C-Thru Adult Armboard
In Commercial Distribution

  • 00810045920320 ()
C-902717-CUSTOM - 11" x 25" x 11"

  • Orthopaedic operating table top

Green X 12 - 08800016401844

PHT-75CHS(RC12X8.5)(US)/P(W-PAN P)+C(W-CEPH)+CT(W-PAN P)+TUBE/MASTER Green X 12 (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X 12 is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector.
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016401844 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green X 12 - 08800016401837

PHT-75CHS(SP12X8.5)(US)/P(W-PAN P)+CT(W-PAN P)+TUBE/MASTER Green X 12 (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X 12 is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector.
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016401837 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green X 18 - 08800016400793

Dental Computed Tomography X-ray System functioning Pano/CT/CEPH Image Acquisition Xmaru1524CF Master Plus OP, Xmaru2602CF/W-Ceph(P)/MASTER
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016400793 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green X 18 - 08800016400786

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1524CF Master Plus OP
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016400786 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

iN∫X ® - 00190790001339

iN∫X ® for iN∫Line™, Integrated Patient Transport & Loading System – DWL
FERNO-WASHINGTON, INC.
0015811
In Commercial Distribution

  • 00190790001339 ()


  • Ambulance stretcher, electrohydraulic

iN∫X ® - 00190790001322

iN∫X ® for 175, Integrated Patient Transport & Loading System – DWL,SX
FERNO-WASHINGTON, INC.
0015810
Not in Commercial Distribution

  • 00190790001322 ()


  • Ambulance stretcher, electrohydraulic

iN∫X ® - 00190790001308

iN∫X ® for 175, Integrated Patient Transport & Loading System – DWL
FERNO-WASHINGTON, INC.
0015808
Not in Commercial Distribution

  • 00190790001308 ()


  • Ambulance stretcher, electrohydraulic

iN∫X® - 00190790000004

iN∫X® for iN∫Line™, Integrated Patient Transport & Loading System
FERNO-WASHINGTON, INC.
0015803
In Commercial Distribution

  • 00190790000004 ()


  • Ambulance stretcher, electrohydraulic

Polaris X™ - 08714729270188

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0047005D0
In Commercial Distribution

  • 08714729270188 ()

  • 10 mm Length
  • 2 mm Length
  • 6 F Diameter
  • 2.00 mm Diameter


  • Cardiac mapping catheter, percutaneous, single-use

Polaris X™ - 08714729270171

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0047004D0
In Commercial Distribution

  • 08714729270171 ()

  • 2 mm Length
  • 8 mm Length
  • 6 F Diameter
  • 2.00 mm Diameter


  • Cardiac mapping catheter, percutaneous, single-use

Polaris X™ - 08714729270164

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0047003D0
In Commercial Distribution

  • 08714729270164 ()

  • 2.5 mm Length
  • 5 mm Length
  • 2.00 mm Diameter
  • 6 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use

Polaris X™ - 08714729270140

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0047001D0
In Commercial Distribution

  • 08714729270140 ()

  • 2.00 mm Diameter
  • 6 F Diameter
  • 5 mm Length


  • Cardiac mapping catheter, percutaneous, single-use

Polaris X™ - 08714729270133

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0047000D0
In Commercial Distribution

  • 08714729270133 ()

  • 2.5 mm Length
  • 2.00 mm Diameter
  • 6 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use

Polaris X™ - 08714729269915

Catheter Cable, Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M004626S0
Not in Commercial Distribution

  • 08714729269915 ()


  • Electrical-only medical device connection cable, reusable

Polaris X™ - 08714729269779

Catheter Cable, Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M0045454S0
In Commercial Distribution

  • 08714729269779 ()
M0045454S0

  • Electrical-only medical device connection cable, reusable

X Plate Trials - 00840118106832

surgical instrument or accessory for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FIS 611
In Commercial Distribution

  • 00840118106832 ()


  • Surgical instrument/implant depth limiter, reusable

Med X Change - 00817613020109

Foot Pedal - Med X Change Brand
Nds Surgical Imaging LLC
DRS030
Not in Commercial Distribution

  • 00817613020109 ()


  • Foot-switch, electrical

K-4 D³X - 00817012022131

Alternating Pressure with Low Air Loss and Support Air Cushion Bariatric Mattress System, 84" x 54" x 10"
KAP MEDICAL
K-4BMS84X54SAC
In Commercial Distribution

  • 00817012022131 ()
K-4BMS84X54SAC

  • Low-air-loss bed

K-4 D³X - 00817012022070

Alternating Pressure with Low Air Loss Expandable Mattress System, 80"-84"-88" x 36"-42"-48" x 10"
KAP MEDICAL
K-4UHSXMS
In Commercial Distribution

  • 00817012022070 ()
SkinGuardXMS

  • Low-air-loss bed

K-4 D³X - 00817012021899

Alternating Pressure with Low Air Loss Mattress System, 80" x 36" x 8"
KAP MEDICAL
SkinGuardMS8
In Commercial Distribution

  • 00817012021899 ()
SkinGuardMS8

  • Low-air-loss bed

K-4 D³X - 00817012021165

Alternating Pressure with Low Air Loss Expandable Mattress System, 80"-84"-88" x 36"-42"-48" x 10"
KAP MEDICAL
K-4XMS
In Commercial Distribution

  • 00817012021165 ()
K-4XMS

  • Low-air-loss bed

K-4 D³X - 00817012021158

Alternating Pressure with Low Air Loss Universal Mattress System, 84" x 36"x 8"-10"
KAP MEDICAL
K-4UMS
In Commercial Distribution

  • 00817012021158 ()
K-4UMS

  • Low-air-loss bed

K-4 D³X - 00817012021141

Alternating Pressure with Low Air Loss Expandable Mattress System, 80"-84"-88" x 36"-42"-48" x 10"
KAP MEDICAL
K-4UHSXMS
In Commercial Distribution

  • 00817012021141 ()
K-4UHSXMS

  • Low-air-loss bed

K-4 D³X - 00817012021134

Alternating Pressure with Low Air Loss and Raised Side Bolster Mattress System, 80" x 48" x 10"
KAP MEDICAL
K-4RSB48
In Commercial Distribution

  • 00817012021134 ()
K-4RSB48

  • Low-air-loss bed

K-4 D³X - 00817012021127

Alternating Pressure with Low Air Loss and Raised Side Bolster Mattress System, 80" x 36" x 10"
KAP MEDICAL
K-4RSB
In Commercial Distribution

  • 00817012021127 ()
K-4RSB

  • Low-air-loss bed

K-4 D³X - 00817012021110

Alternating Pressure with Low Air Loss and Support Air Cushion Mattress System, 84" x 36" x 10"
KAP MEDICAL
K-4MS84SAC
In Commercial Distribution

  • 00817012021110 ()
K-4MS84SAC

  • Low-air-loss bed

K-4 D³X - 00817012021103

Alternating Pressure with Low Air Loss Mattress System, 80" x 36" x 8"
KAP MEDICAL
K-4MS8
In Commercial Distribution

  • 00817012021103 ()
K-4MS8

  • Low-air-loss bed

K-4 D³X - 00817012021097

Alternating Pressure with Low Air Loss Mattress System, 84" x 36" x 7"
KAP MEDICAL
K-4MS7X84
In Commercial Distribution

  • 00817012021097 ()
K-4MS7X84

  • Low-air-loss bed

K-4 D³X - 00817012021080

Alternating Pressure with Low Air Loss Mattress System, 80" x 76" x 10"
KAP MEDICAL
K-4MS76
In Commercial Distribution

  • 00817012021080 ()
K-4MS76

  • Low-air-loss bed

K-4 D³X - 00817012021073

Alternating Pressure with Low Air Loss Mattress System, 80" x 36" x 7"
KAP MEDICAL
K-4MS7
In Commercial Distribution

  • 00817012021073 ()
K-4MS7

  • Low-air-loss bed

K-4 D³X - 00817012021066

Alternating Pressure with Low Air Loss Mattress System, 84" x 36" x 10"
KAP MEDICAL
K-4MS36X84
In Commercial Distribution

  • 00817012021066 ()
K-4MS36X84

  • Low-air-loss bed

K-4 D³X - 00817012021059

Alternating Pressure with Low Air Loss Mattress System, 80" x 36" x 10"
KAP MEDICAL
K-4MS
In Commercial Distribution

  • 00817012021059 ()
K-4MS

  • Low-air-loss bed

K-4 D³X - 00817012021042

Alternating Pressure with Low Air Loss Mattress Overlay System, 80" x 36" x 5"
KAP MEDICAL
K-4COS
In Commercial Distribution

  • 00817012021042 ()
K-4COS

  • Low-air-loss bed

K-4 D³X - 00817012021035

Alternating Pressure with Low Air Loss and Support Air Cushion Bariatric Mattress System, 84" x 48" x 10"
KAP MEDICAL
K-4BMS84X48SAC
In Commercial Distribution

  • 00817012021035 ()
K-4BMS84X48SAC

  • Low-air-loss bed

K-4 D³X - 00817012021028

Alternating Pressure with Low Air Loss and Support Air Cushion Bariatric Mattress System, 84" x 42" x 10"
KAP MEDICAL
K-4BMS84X42SAC
In Commercial Distribution

  • 00817012021028 ()
K-4BMS84X42SAC

  • Low-air-loss bed

K-4 D³X - 00817012021011

Alternating Pressure with Low Air Loss and Side Bolster Mattress System, 80" x 42" x 10"
KAP MEDICAL
K-4BMS42
In Commercial Distribution

  • 00817012021011 ()
K-4BMS42

  • Low-air-loss bed

K-4 D³X - 00817012021004

Alternating Pressure with Low Air Loss and Side Bolster Mattress System, 80" x 39" x 10"
KAP MEDICAL
K-4BMS39
In Commercial Distribution

  • 00817012021004 ()
K-4BMS39

  • Low-air-loss bed

K-4 D³X - 00817012020991

Alternating Pressure with Low Air Loss Mattress System, 80" x 54" x 10"
KAP MEDICAL
K-4B54
In Commercial Distribution

  • 00817012020991 ()
K-4B54

  • Low-air-loss bed

K-4 D³X - 00817012020984

Alternating Pressure with Low Air Loss Mattress System, 86" x 48" x 10"
KAP MEDICAL
K-4B48X86
In Commercial Distribution

  • 00817012020984 ()
K-4B48X86

  • Low-air-loss bed

K-4 D³X - 00817012020977

Alternating Pressure with Low Air Loss Mattress System, 84" x 48" x 10"
KAP MEDICAL
K-4B48X84
In Commercial Distribution

  • 00817012020977 ()
K-4B48X84

  • Low-air-loss bed

K-4 D³X - 00817012020960

Alternating Pressure with Low Air Loss Mattress System, 80" x 48" x 10"
KAP MEDICAL
K-4B48
In Commercial Distribution

  • 00817012020960 ()
K-4B48

  • Low-air-loss bed

K-4 D³X - 00817012020953

Alternating Pressure with Low Air Loss Mattress System, 80" x 42" x 10"
KAP MEDICAL
K-4B42
In Commercial Distribution

  • 00817012020953 ()
K-4B42

  • Low-air-loss bed

K-4 D³X - 00817012020946

Alternating Pressure with Low Air Loss Mattress System, 80" x 39" x 10"
KAP MEDICAL
K-4B39
In Commercial Distribution

  • 00817012020946 ()
K-4B39

  • Low-air-loss bed

K-4 D³X - 00817012030389

Alternating Pressure, Low Air Loss, Variable Length, Mattress System, 80"~85"~90"x 36" x 8"
KAP MEDICAL
K-4MS8X88
In Commercial Distribution

  • 00817012030389 ()
K-4MS8X88

  • Low-air-loss bed

K-4 D³X - 00817012030372

No Description
KAP MEDICAL
K-4 BB 220V
In Commercial Distribution

  • 00817012030372 ()
K-4 BB 220V

  • Low-air-loss bed

K-4 D³X - 00817012029703

Alternating Pressure, Pulsation, True Low Air Loss 8" High 48" Wide Mattress, Bariatric System
KAP MEDICAL
K-4-B48-8
In Commercial Distribution

  • 00817012029703 ()
K-4-B48-8

  • Low-air-loss bed

K-4 D³X - 00817012029697

Alternating Pressure, Pulsation, True Low Air Loss 8" High 42" Wide Mattress, Briatric System
KAP MEDICAL
K-4-B42-8
In Commercial Distribution

  • 00817012029697 ()
K-4-B42-8

  • Low-air-loss bed

K-4 D³X - 00817012029680

Alternating Pressure, Pulsation, True Low Air Loss Even Side Bolster Mattress, Standard System
KAP MEDICAL
K-4-ESB
In Commercial Distribution

  • 00817012029680 ()
K-4-ESB

  • Low-air-loss bed

K-4 D³X - 00817012029673

Alternating Pressure, Pulsation, True Low Air Loss 10" High, 80"~85"~90" Variable Length Long Mattress, Standard System
KAP MEDICAL
K-4-VL-MS
In Commercial Distribution

  • 00817012029673 ()
K-4-VL-MS

  • Low-air-loss bed
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