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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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Koya Medical - 00850012532118

Dayspring Charger
Koya Medical, Inc.
F-0006-01
In Commercial Distribution

  • 00850012532118 ()
F-0006-01

  • Wearable sequential venous compression system

Koya Medical - 00850012532101

Dayspring Controller
Koya Medical, Inc.
F-0002-01
In Commercial Distribution

  • 00850012532101 ()
F-0002-01

  • Wearable sequential venous compression system

Koya Medical - 00850012532095

Gauntlet, Small
Koya Medical, Inc.
F-0030-01
In Commercial Distribution

  • 00850012532095 ()
F-0030-01

  • Wearable sequential venous compression system

Koya Medical - 00850012532088

Gauntlet, Medium
Koya Medical, Inc.
F-0030-02
In Commercial Distribution

  • 00850012532088 ()
F-0030-02

  • Wearable sequential venous compression system

Koya Medical - 00850012532071

Gauntlet, Large
Koya Medical, Inc.
F-0030-03
In Commercial Distribution

  • 00850012532071 ()
F-0030-03

  • Wearable sequential venous compression system

Koya Medical - 00850012532064

Gauntlet, X-Large
Koya Medical, Inc.
F-0030-04
In Commercial Distribution

  • 00850012532064 ()
F-0030-04

  • Wearable sequential venous compression system

Koya Medical - 00850012532057

Arm Liner, Large
Koya Medical, Inc.
F-0020-02
In Commercial Distribution

  • 00850012532057 ()
F-0020-02

  • Wearable sequential venous compression system

Koya Medical - 00850012532040

Arm Liner, Medium
Koya Medical, Inc.
F-0020-02
In Commercial Distribution

  • 00850012532040 ()
F-0020-02

  • Wearable sequential venous compression system

Koya Medical - 00850012532033

Arm Liner, Small
Koya Medical, Inc.
F-0020-01
In Commercial Distribution

  • 00850012532033 ()
F-0020-01

  • Wearable sequential venous compression system

Koya Medical - 00850012532026

Arm Garmet, Dayspring, Long
Koya Medical, Inc.
F-0010-03
In Commercial Distribution

  • 00850012532026 ()
F-0010-03

  • Wearable sequential venous compression system

Koya Medical - 00850012532019

Arm Garmet, Dayspring, Medium
Koya Medical, Inc.
F-0010-02
In Commercial Distribution

  • 00850012532019 ()
F-0010-02

  • Wearable sequential venous compression system

Koya Medical - 00850012532002

Arm Garmet, Dayspring, Short
Koya Medical, Inc.
F-0010-01
In Commercial Distribution

  • 00850012532002 ()
F-0010-01

  • Wearable sequential venous compression system

Foray - 00850012508014

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 ® - 00850012315957

ARVIS Global Shoulder Navigation System
KICO KNEE INNOVATION COMPANY PTY LIMITED
IN-50010
In Commercial Distribution

  • 00850012315957 ()


  • Orthopaedic stereotactic surgery system

ARVIS ® - 00850012315940

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 ® - 00850012315902

ARVIS Shoulder Surgical Navigation System
KICO KNEE INNOVATION COMPANY PTY LIMITED
22300
In Commercial Distribution

  • 00850012315902 ()


  • Orthopaedic stereotactic surgery system

ARVIS ® - 00850012315896

Reverse Registration Tool
KICO KNEE INNOVATION COMPANY PTY LIMITED
22200
In Commercial Distribution

  • 00850012315896 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315889

Registration Stylus
KICO KNEE INNOVATION COMPANY PTY LIMITED
22100
In Commercial Distribution

  • 00850012315889 ()


  • Surgical optical-tracking spatial marker, reusable

ARVIS ® - 00850012315872

ARVIS Shoulder Instrument Set, Packaged
KICO KNEE INNOVATION COMPANY PTY LIMITED
27200
In Commercial Distribution

  • 00850012315872 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315865

Tracker A, Mechanical
KICO KNEE INNOVATION COMPANY PTY LIMITED
24000
In Commercial Distribution

  • 00850012315865 ()


  • Surgical optical-tracking spatial marker, reusable

ARVIS ® - 00850012315858

Mechanical Mount
KICO KNEE INNOVATION COMPANY PTY LIMITED
23000
In Commercial Distribution

  • 00850012315858 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315841

T7 Adapter Kit
KICO KNEE INNOVATION COMPANY PTY LIMITED
21700
In Commercial Distribution

  • 00850012315841 ()


  • Orthopaedic stereotactic surgery system

ARVIS ® - 00850012315827

ARVIS Shoulder Instrument Set
KICO KNEE INNOVATION COMPANY PTY LIMITED
21300
In Commercial Distribution

  • 00850012315827 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315803

ARVIS Hip and Knee Instrument Set
KICO KNEE INNOVATION COMPANY PTY LIMITED
21200
In Commercial Distribution

  • 00850012315803 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315797

Instrument Tray Base
KICO KNEE INNOVATION COMPANY PTY LIMITED
20000
In Commercial Distribution

  • 00850012315797 ()


  • Instrument tray, reusable

ARVIS ® - 00850012315780

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

  • 00850012315780 ()


  • Instrument tray, reusable

ARVIS ® - 00850012315773

Flex Jack
KICO KNEE INNOVATION COMPANY PTY LIMITED
21000
In Commercial Distribution

  • 00850012315773 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315766

Tibial Mount, Right
KICO KNEE INNOVATION COMPANY PTY LIMITED
20400
In Commercial Distribution

  • 00850012315766 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315759

Tibial Mount, Left
KICO KNEE INNOVATION COMPANY PTY LIMITED
20300
In Commercial Distribution

  • 00850012315759 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315742

Adjustable Mount 2
KICO KNEE INNOVATION COMPANY PTY LIMITED
20200
In Commercial Distribution

  • 00850012315742 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315735

Adjustable Mount 1
KICO KNEE INNOVATION COMPANY PTY LIMITED
20100
In Commercial Distribution

  • 00850012315735 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315711

Resection Check Tool
KICO KNEE INNOVATION COMPANY PTY LIMITED
19900
In Commercial Distribution

  • 00850012315711 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315704

Precision Cutting Block
KICO KNEE INNOVATION COMPANY PTY LIMITED
19200
In Commercial Distribution

  • 00850012315704 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315698

Precision Adjustable Distal Guide
KICO KNEE INNOVATION COMPANY PTY LIMITED
19100
In Commercial Distribution

  • 00850012315698 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315681

Empowr Femoral Sizer Adapter
KICO KNEE INNOVATION COMPANY PTY LIMITED
18900
In Commercial Distribution

  • 00850012315681 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315650

Registration Stylus
KICO KNEE INNOVATION COMPANY PTY LIMITED
18600
In Commercial Distribution

  • 00850012315650 ()


  • Surgical optical-tracking spatial marker, reusable

ARVIS ® - 00850012315643

Reference Pin Guide
KICO KNEE INNOVATION COMPANY PTY LIMITED
18500
In Commercial Distribution

  • 00850012315643 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315629

Glenoid Drill Guide
KICO KNEE INNOVATION COMPANY PTY LIMITED
18300
In Commercial Distribution

  • 00850012315629 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315605

Pin 2-Pack, 4mm x 115mm
KICO KNEE INNOVATION COMPANY PTY LIMITED
17900
In Commercial Distribution

  • 00850012315605 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315599

T7 Mounting Kit
KICO KNEE INNOVATION COMPANY PTY LIMITED
17600
In Commercial Distribution

  • 00850012315599 ()


  • Orthopaedic stereotactic surgery system

ARVIS ® - 00850012315582

ARVIS Installation Kit
KICO KNEE INNOVATION COMPANY PTY LIMITED
17700
In Commercial Distribution

  • 00850012315582 ()


  • Orthopaedic stereotactic surgery system

ARVIS ® - 00850012315575

Flyte Mounting Kit
KICO KNEE INNOVATION COMPANY PTY LIMITED
17500
In Commercial Distribution

  • 00850012315575 ()


  • Orthopaedic stereotactic surgery system

ARVIS ® - 00850012315568

ARVIS Headband
KICO KNEE INNOVATION COMPANY PTY LIMITED
17100
In Commercial Distribution

  • 00850012315568 ()


  • Orthopaedic stereotactic surgery system

ARVIS ® - 00850012315551

Pin Caddy Lid
KICO KNEE INNOVATION COMPANY PTY LIMITED
17300
In Commercial Distribution

  • 00850012315551 ()


  • Instrument tray, reusable

ARVIS ® - 00850012315544

Pin Caddy
KICO KNEE INNOVATION COMPANY PTY LIMITED
17200
In Commercial Distribution

  • 00850012315544 ()


  • Instrument tray, reusable

ARVIS ® - 00850012315537

ARVIS Hip and Knee Instrument Set
KICO KNEE INNOVATION COMPANY PTY LIMITED
18000
In Commercial Distribution

  • 00850012315537 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315520

Instrument Tray Base
KICO KNEE INNOVATION COMPANY PTY LIMITED
17000
In Commercial Distribution

  • 00850012315520 ()


  • Instrument tray, reusable

ARVIS ® - 00850012315513

Registration Stylus
KICO KNEE INNOVATION COMPANY PTY LIMITED
16500
In Commercial Distribution

  • 00850012315513 ()


  • Surgical optical-tracking spatial marker, reusable

ARVIS ® - 00850012315506

Tracker A
KICO KNEE INNOVATION COMPANY PTY LIMITED
16400
In Commercial Distribution

  • 00850012315506 ()


  • Surgical optical-tracking spatial marker, reusable

ARVIS ® - 00850012315490

Impactor Adapter, DJO
KICO KNEE INNOVATION COMPANY PTY LIMITED
15900
In Commercial Distribution

  • 00850012315490 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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