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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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Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-02
In Commercial Distribution

  • 00850012532132 ()
F-0100-02

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-01
Koya Medical, Inc.
F-0100-01
In Commercial Distribution

  • 00850012532125 ()
F-0100-01

  • Wearable sequential venous compression system
Dayspring Charger
Koya Medical, Inc.
F-0006-01
In Commercial Distribution

  • 00850012532118 ()
F-0006-01

  • Wearable sequential venous compression system
Dayspring Controller
Koya Medical, Inc.
F-0002-01
In Commercial Distribution

  • 00850012532101 ()
F-0002-01

  • Wearable sequential venous compression system
Gauntlet, Small
Koya Medical, Inc.
F-0030-01
In Commercial Distribution

  • 00850012532095 ()
F-0030-01

  • Wearable sequential venous compression system
Gauntlet, Medium
Koya Medical, Inc.
F-0030-02
In Commercial Distribution

  • 00850012532088 ()
F-0030-02

  • Wearable sequential venous compression system
Gauntlet, Large
Koya Medical, Inc.
F-0030-03
In Commercial Distribution

  • 00850012532071 ()
F-0030-03

  • Wearable sequential venous compression system
Gauntlet, X-Large
Koya Medical, Inc.
F-0030-04
In Commercial Distribution

  • 00850012532064 ()
F-0030-04

  • Wearable sequential venous compression system
Arm Liner, Large
Koya Medical, Inc.
F-0020-02
In Commercial Distribution

  • 00850012532057 ()
F-0020-02

  • Wearable sequential venous compression system
Arm Liner, Medium
Koya Medical, Inc.
F-0020-02
In Commercial Distribution

  • 00850012532040 ()
F-0020-02

  • Wearable sequential venous compression system
Arm Liner, Small
Koya Medical, Inc.
F-0020-01
In Commercial Distribution

  • 00850012532033 ()
F-0020-01

  • Wearable sequential venous compression system
Arm Garmet, Dayspring, Long
Koya Medical, Inc.
F-0010-03
In Commercial Distribution

  • 00850012532026 ()
F-0010-03

  • Wearable sequential venous compression system
Arm Garmet, Dayspring, Medium
Koya Medical, Inc.
F-0010-02
In Commercial Distribution

  • 00850012532019 ()
F-0010-02

  • Wearable sequential venous compression system
Arm Garmet, Dayspring, Short
Koya Medical, Inc.
F-0010-01
In Commercial Distribution

  • 00850012532002 ()
F-0010-01

  • Wearable sequential venous compression system
Foray Design's Spring is an all-wheeled mobility aid (rolling walker) in the form of a waist-high, foldable framework with a continuous handgrip and four legs designed to provide a stable support to a person with a disability, a geriatric or an infirm person when standing or ambulating; it may also be used during rehabilitation. It includes a seat on which the user can rest and it is constructed of lightweight material and in the form of a mobile support structure which the user holds and pushes in front of them as they walk. It is foldable for storage and transportation, and includes a braking mechanism.
EKT LLC
1
In Commercial Distribution

  • 00850012508014 ()

  • Height: 37.2 Inch
  • Length: 27.32 Inch
  • Depth: 26.57 Inch


  • Handgrip disability-assistive walker, non-powered, foldable
ARVIS Global Shoulder Navigation System
KICO KNEE INNOVATION COMPANY PTY LIMITED
IN-50010
In Commercial Distribution

  • 00850012315957 ()


  • Orthopaedic stereotactic surgery system
ARVIS Global Hip and Knee 2.0 Navigation System
KICO KNEE INNOVATION COMPANY PTY LIMITED
IN-50000
In Commercial Distribution

  • 00850012315940 ()


  • Orthopaedic stereotactic surgery system
ARVIS Shoulder Surgical Navigation System
KICO KNEE INNOVATION COMPANY PTY LIMITED
22300
In Commercial Distribution

  • 00850012315902 ()


  • Orthopaedic stereotactic surgery system
Reverse Registration Tool
KICO KNEE INNOVATION COMPANY PTY LIMITED
22200
In Commercial Distribution

  • 00850012315896 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Registration Stylus
KICO KNEE INNOVATION COMPANY PTY LIMITED
22100
In Commercial Distribution

  • 00850012315889 ()


  • Surgical optical-tracking spatial marker, reusable
ARVIS Shoulder Instrument Set, Packaged
KICO KNEE INNOVATION COMPANY PTY LIMITED
27200
In Commercial Distribution

  • 00850012315872 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tracker A, Mechanical
KICO KNEE INNOVATION COMPANY PTY LIMITED
24000
In Commercial Distribution

  • 00850012315865 ()


  • Surgical optical-tracking spatial marker, reusable
Mechanical Mount
KICO KNEE INNOVATION COMPANY PTY LIMITED
23000
In Commercial Distribution

  • 00850012315858 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
T7 Adapter Kit
KICO KNEE INNOVATION COMPANY PTY LIMITED
21700
In Commercial Distribution

  • 00850012315841 ()


  • Orthopaedic stereotactic surgery system
ARVIS Shoulder Instrument Set
KICO KNEE INNOVATION COMPANY PTY LIMITED
21300
In Commercial Distribution

  • 00850012315827 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ARVIS Hip and Knee Instrument Set
KICO KNEE INNOVATION COMPANY PTY LIMITED
21200
In Commercial Distribution

  • 00850012315803 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Instrument Tray Base
KICO KNEE INNOVATION COMPANY PTY LIMITED
20000
In Commercial Distribution

  • 00850012315797 ()


  • Instrument tray, reusable
Instrument Tray Base,Shoulder
KICO KNEE INNOVATION COMPANY PTY LIMITED
21100
In Commercial Distribution

  • 00850012315780 ()


  • Instrument tray, reusable
Flex Jack
KICO KNEE INNOVATION COMPANY PTY LIMITED
21000
In Commercial Distribution

  • 00850012315773 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Mount, Right
KICO KNEE INNOVATION COMPANY PTY LIMITED
20400
In Commercial Distribution

  • 00850012315766 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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