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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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ZIRKONZAHN.Implant-Planner - D800SY1600

Rights of use Zirkonzahn.Implant-Planner The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for the duration of 12 months! Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner
ZIRKONZAHN SRL
SY1600
In Commercial Distribution

  • D800SY1600 ()


  • Dental treatment application software

Coapt Evaluation Kit - B618Q1

The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is an accessory intended to be used during the planning and alignment of myoelectric control contact locations for an upper limb prosthetic socket.
COAPT LLC
1
In Commercial Distribution

  • B618Q1 ()


  • Bioelectrical signal analysis software

iOptima APP - J00714000630631

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software

NONE - B006EMGVIEW0

No Description
Neurovision Medical Products, Inc.
NONE
In Commercial Distribution

  • B006EMGVIEW0 ()


  • Bioelectrical signal analysis software

BC - B202BCSEG0

No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software) Segmental
In Commercial Distribution

  • B202BCSEG0 ()
BCSEG

  • Bioelectrical signal analysis software

BC - B202BC0

No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software)
In Commercial Distribution

  • B202BC0 ()
BC

  • Bioelectrical signal analysis software

SHOEBOX AUDIOMETRY - B348SHOEBOXAUDIOMETER0

No Description
SHOEBOX Ltd
SHOEBOXAUDIOMETER
In Commercial Distribution

  • B348SHOEBOXAUDIOMETER0 ()


  • Tone audiometer

MedTrakVNG Goggle - B292M9205200

No Description
MEDTRAK VNG, INC.
M920520
In Commercial Distribution

  • B292M9205200 ()


  • Eye movement analysis system

MedTrakVNG Interface Controller - B292M9203020

No Description
MEDTRAK VNG, INC.
M920302
In Commercial Distribution

  • B292M9203020 ()


  • Eye movement analysis system

MobiTrakVNG Receiver - B292M9174150

No Description
MEDTRAK VNG, INC.
M917415
In Commercial Distribution

  • B292M9174150 ()


  • Eye movement analysis system
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