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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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BioStamp® - B493BRCA05

Adhesive applicator
MC10, INC.
BRCA05
Not in Commercial Distribution

  • B493BRCA05 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software

BioStamp® - B493BRCA02

Adhesive with hydrogel
MC10, INC.
BRCA02
Not in Commercial Distribution

  • B493MC0009 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder

Localite TMS Navigator TS - G076A010233AM3N40

No Description
LOCALITE GmbH
Functional Data (Software Module)
In Commercial Distribution

10233

  • Stereotactic neuronavigation/planning system

Localite TMS Navigator TS - G076A010233AM3N30

No Description
LOCALITE GmbH
Functional Data (Software Module)
Not in Commercial Distribution

  • G076A010233AM3N30 ()
10233

  • Stereotactic neuronavigation/planning system

NA - EPTWS1000090

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
UniSoft software, Edition 2000
In Commercial Distribution

  • EPTWS1000090 ()
S100009

  • Multi-modality therapeutic radiation phantom, anthropomorphic

Connection Kit short - E27668312960

Primescan Connect OEM Connection Kit short
SIRONA Dental Systems GmbH
6831296
In Commercial Distribution

  • E27668312960 ()
6831296

  • Dental milling system, CAD/CAM, chairside

Connection Kit long - E27668287300

Primescan Connect OEM Connection Kit long
SIRONA Dental Systems GmbH
6828730
In Commercial Distribution

  • E27668287300 ()
6828730

  • Dental milling system, CAD/CAM, chairside

Clinician Kit - E27668283750

Primescan Connect OEM Clinician Kit
SIRONA Dental Systems GmbH
6828375
In Commercial Distribution

  • E27668283750 ()
6828375

  • Dental milling system, CAD/CAM, chairside

Primescan Connect - E27667954910

Primescan Connect
SIRONA Dental Systems GmbH
6795491
In Commercial Distribution

  • E27667954910 ()
6795491

  • Dental milling system, CAD/CAM, chairside

Orthophos E - E27667084290

Orthophos E
SIRONA Dental Systems GmbH
6708429
In Commercial Distribution

  • E27667084290 ()


  • Stationary panoramic dental x-ray system, digital
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