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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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DEXcam4™ Intra-oral camera - EKAV101149960

Digital intraoral camera
DEXIS LLC
1.011.4996
In Commercial Distribution

  • EKAV101149960 ()
PLU7610K

  • Multi-purpose digital medical camera

DEXcam4™ Intra-oral camera - EKAV101149840

No Description
DEXIS LLC
1.011.4984
In Commercial Distribution

  • EKAV101149840 ()
PLU760

  • Multi-purpose digital medical camera

Gendex GXC-300™ intraoral camera - EKAV100719700

Digital intraoral cameraDigital intraoral camera
GENDEX CORP.
1.007.1970
In Commercial Distribution

  • EKAV100719700 ()
120 0209G1

  • Multi-purpose digital medical camera

DEXcam3™ intraoral cameras - EKAV100719690

Digital intraoral camera
DEXIS LLC
1.007.1969
In Commercial Distribution

  • EKAV100719690 ()
PLU791

  • Multi-purpose digital medical camera

DEXcam3™ intraoral cameras - EKAV100713330

Digital intraoral camera
DEXIS LLC
1.007.1333
In Commercial Distribution

  • EKAV100713330 ()
PLU790

  • Multi-purpose digital medical camera

GD - 00862186000386

The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems.
General Devices
Rosetta-Lt Data Translator
Not in Commercial Distribution

  • 00862186000386 ()
040-184-7100

  • Medical networking interface unit

GD - 00862186000379

The CAREpoint Workstation (Version 1 and 2) communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes.
General Devices
CAREpoint Workstation
Not in Commercial Distribution

  • 00862186000379 ()
040-183-4000

  • Medical networking interface unit

Polytel - 00861700000376

Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided: "B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
Polymap Wireless
GMA2-L
In Commercial Distribution

  • 00861700000376 ()


  • Medical networking interface unit

Polytel - 00861700000369

Cable to connect Polytel PWR-09-02 GMA2 to Bayer family glucose meters
Polymap Wireless
"B" cable for GMA2
In Commercial Distribution

  • 00861700000369 ()
RYPLX03

  • Medical networking interface unit

Polytel - 00861700000352

Cable to be used with Polytel PWR-09-02 GMA2 to support Abbott glucose meters
Polymap Wireless
"A" cable for GMA2
In Commercial Distribution

  • 00861700000352 ()
RPLYX02

  • Medical networking interface unit
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