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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CRYOTHERAPY V 236ML REPLACEMENT CANISTER
MEDLINE INDUSTRIES, INC.
OTCM1500
In Commercial Distribution

  • 10193489084771 ()
OTCM1500

  • Wart-removal cryogenic kit
The Venowave VW5 series comprises compact, battery-operated non-pneumatic, non-sequential, peristaltic wave compression pumps designed to generate wave-form motion. When securely fastened below the knee on the calf, these pumps create compression, leading to an increased upward volumetric displacement of venous and lymph fluid. The device is used for Management of the symptoms of post thrombolytic syndrome (PTS), Prevention of deep vein thrombosis (DVT), Prevention of primary thrombosis, Treatment of lymphedema, Diminishing post-operative pain and swelling, Treatment of leg swelling due to vascular insufficiency, Treatment of varicose veins Treatment of chronic venous insufficiency.
Therma Bright Inc
VW5-6
In Commercial Distribution

  • 00627843553601 ()
  • 00627843553595 ()
  • 00683601000053 ()

  • Weight: 270 Gram
  • Length: 190 Millimeter
  • Width: 100 Millimeter
  • Height: 48 Millimeter


  • Wearable sequential venous compression system
Uni-Gold™ Recombigen® HIV-1/2
TRINITY BIOTECH PUBLIC LIMITED COMPANY
1206506
Not in Commercial Distribution

  • 05391516746106 ()

  • 20 Tests
1206506

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Cryogenic Skin Tag Removal
Dgi Group LLC
AZ-6055
In Commercial Distribution

  • 00850001389242 ()


  • Wart-removal cryogenic kit
Cryogenic Skin Tag Remover
Dgi Group LLC
AZ-6055
In Commercial Distribution

  • 00850001389167 ()


  • Wart-removal cryogenic kit
LEG GARMENT, DAYSPRING, LONG, RIGHT
Koya Medical, Inc.
F-0040-08
Not in Commercial Distribution

  • 00850012532798 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, LONG, LEFT
Koya Medical, Inc.
F-0040-07
Not in Commercial Distribution

  • 00850012532781 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, MEDIUM, RIGHT
Koya Medical, Inc.
F-0040-06
Not in Commercial Distribution

  • 00850012532774 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, MEDIUM, LEFT
Koya Medical, Inc.
F-0040-05
Not in Commercial Distribution

  • 00850012532767 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, SHORT, RIGHT
Koya Medical, Inc.
F-0040-04
Not in Commercial Distribution

  • 00850012532750 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, SHORT, LEFT
Koya Medical, Inc.
F-0040-03
Not in Commercial Distribution

  • 00850012532743 ()


  • Wearable sequential venous compression system
LOWER LEG GARMENT
Koya Medical, Inc.
F-0050-02
Not in Commercial Distribution

  • 00850012532736 ()


  • Wearable sequential venous compression system
ARM GARMENT, LONG
Koya Medical, Inc.
F-0010-09
Not in Commercial Distribution

  • 00850012532729 ()


  • Wearable sequential venous compression system
ARM GARMENT, MED
Koya Medical, Inc.
F-0010-08
Not in Commercial Distribution

  • 00850012532712 ()


  • Wearable sequential venous compression system
ARM GARMENT, SHORT
Koya Medical, Inc.
F-0010-07
Not in Commercial Distribution

  • 00850012532705 ()


  • Wearable sequential venous compression system
ARM GARMENT, DAYSPRING, LONG
Koya Medical, Inc.
F-0010-06
In Commercial Distribution

  • 00850012532699 ()


  • Wearable sequential venous compression system
ARM GARMENT, DAYSPRING, MEDIUM
Koya Medical, Inc.
F-0010-05
In Commercial Distribution

  • 00850012532682 ()


  • Wearable sequential venous compression system
ARM GARMENT, DAYSPRING, SHORT
Koya Medical, Inc.
F-0010-04
In Commercial Distribution

  • 00850012532675 ()


  • Wearable sequential venous compression system
CONTROLLER, DAYSPRING, LITE
Koya Medical, Inc.
F-0085-01
In Commercial Distribution

  • 00850012532651 ()
F-0085-01

  • Wearable sequential venous compression system
LOWER LEG GARMENT, DAYSPRING
Koya Medical, Inc.
F-0050-01
In Commercial Distribution

  • 00850012532644 ()
F-0050-01

  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, LONG
Koya Medical, Inc.
F-0040-02
In Commercial Distribution

  • 00850012532637 ()
F-0040-02

  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, STANDARD
Koya Medical, Inc.
F-0040-01
In Commercial Distribution

  • 00850012532620 ()
F-0040-01

  • Wearable sequential venous compression system
Dayspring Mobile Application
Koya Medical, Inc.
SW 005
In Commercial Distribution

  • 00850012532613 ()
SW 005

  • Wearable sequential venous compression system
Arm Liner, X-Large
Koya Medical, Inc.
F-0020-04
In Commercial Distribution

  • 00850012532606 ()
F-0020-04

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-23
Koya Medical, Inc.
F-0100-23
In Commercial Distribution

  • 00850012532590 ()
F-0100-23

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, X-Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-47
In Commercial Distribution

  • 00850012532583 ()
F-0100-47

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-47
Koya Medical, Inc.
F-0100-47
In Commercial Distribution

  • 00850012532576 ()
F-0100-47

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, X-Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-46
In Commercial Distribution

  • 00850012532569 ()
F-0100-46

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, X-Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-45
In Commercial Distribution

  • 00850012532552 ()
F-0100-45

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-44
In Commercial Distribution

  • 00850012532545 ()
F-0100-44

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-43
Koya Medical, Inc.
F-0100-43
In Commercial Distribution

  • 00850012532538 ()
F-0100-43

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-42
In Commercial Distribution

  • 00850012532521 ()
F-0100-42

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-41
In Commercial Distribution

  • 00850012532514 ()
F-0100-41

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-39
Koya Medical, Inc.
F-0100-39
In Commercial Distribution

  • 00850012532507 ()
F-0100-39

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-40
In Commercial Distribution

  • 00850012532491 ()
F-0100-40

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-37
In Commercial Distribution

  • 00850012532484 ()
F-0100-37

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-38
In Commercial Distribution

  • 00850012532477 ()
F-0100-38

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-36
In Commercial Distribution

  • 00850012532460 ()
F-0100-36

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-35
Koya Medical, Inc.
F-0100-35
In Commercial Distribution

  • 00850012532453 ()
F-0100-35

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-34
In Commercial Distribution

  • 00850012532446 ()
F-0100-34

  • Wearable sequential venous compression system
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