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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SCHICK33 S2 SENSOR/3.0 CABLE RMA KIT, 9'
SIRONA DENTAL, INC.
100008652
In Commercial Distribution

  • D764100008652 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S2 SENSOR/3.0 CABLE RMA KIT, 6'
SIRONA DENTAL, INC.
100008651
In Commercial Distribution

  • D764100008651 ()


  • Dental digital imaging sensor, intraoral
Schick33 S0 Starter Kit/3.0 Interface 3'
SIRONA DENTAL, INC.
100008641
In Commercial Distribution

  • D7641000086411 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR STARTER KIT/3.0 INTERFACE, 9'
SIRONA DENTAL, INC.
100008640
In Commercial Distribution

  • D764100008640 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR STARTER KIT/3.0 INTERFACE, 6'
SIRONA DENTAL, INC.
100008639
In Commercial Distribution

  • D764100008639 ()


  • Dental digital imaging sensor, intraoral
Schick33 S1 Starter Kit/3.0 Interface 3'
SIRONA DENTAL, INC.
100008638
In Commercial Distribution

  • D7641000086381 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR STARTER KIT/3.0 INTERFACE, 9'
SIRONA DENTAL, INC.
100008637
In Commercial Distribution

  • D764100008637 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR STARTER KIT/3.0 INTERFACE, 6'
SIRONA DENTAL, INC.
100008636
In Commercial Distribution

  • D764100008636 ()


  • Dental digital imaging sensor, intraoral
Schick33 S2 Starter Kit/3.0 Interface 3'
SIRONA DENTAL, INC.
100008635
In Commercial Distribution

  • D7641000086351 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S2 SENSOR STARTER KIT/3.0 INTERFACE, 9'
SIRONA DENTAL, INC.
100008634
In Commercial Distribution

  • D764100008634 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S2 SENSOR STARTER KIT/3.0 INTERFACE, 6'
SIRONA DENTAL, INC.
100008633
In Commercial Distribution

  • D764100008633 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR SHIP KIT/3.0 CABLE, 3'
SIRONA DENTAL, INC.
100008632
In Commercial Distribution

  • D764100008632 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR SHIP KIT/3.0 CABLE, 9'
SIRONA DENTAL, INC.
100008631
In Commercial Distribution

  • D764100008631 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR SHIP KIT/3.0 CABLE, 6'
SIRONA DENTAL, INC.
100008630
In Commercial Distribution

  • D764100008630 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR SHIP KIT/3.0 CABLE, 3'
SIRONA DENTAL, INC.
100008629
In Commercial Distribution

  • D764100008629 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR SHIP KIT/3.0 CABLE, 9'
SIRONA DENTAL, INC.
100008628
In Commercial Distribution

  • D764100008628 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S1 SENSOR SHIP KIT/3.0 CABLE, 6'
SIRONA DENTAL, INC.
100008627
In Commercial Distribution

  • D764100008627 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE, 3'
SIRONA DENTAL, INC.
100008626
In Commercial Distribution

  • D764100008626 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE, 9'
SIRONA DENTAL, INC.
100008625
In Commercial Distribution

  • D764100008625 ()


  • Dental digital imaging sensor, intraoral
SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE 6'
SIRONA DENTAL, INC.
100008624
In Commercial Distribution

  • D764100008624 ()


  • Dental digital imaging sensor, intraoral
XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00195278840233 ()


  • Stationary basic diagnostic x-ray system, digital
XR656HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR656 HD Upgrade
In Commercial Distribution

  • 00195278840226 ()


  • Stationary basic diagnostic x-ray system, digital
Galaxy 2.0 Wall Stand(Insert Left)
GE Hualun Medical Systems Co., Ltd
VMWS-2
In Commercial Distribution

  • 00195278832252 ()


  • Stationary basic diagnostic x-ray system, digital
AMX Navigate Upgrade Designated Medical Device Assembly
GE MEDICAL SYSTEMS, INC.
NAVIGATE UPGRADE
In Commercial Distribution

  • 00195278798374 ()


  • Mobile basic diagnostic x-ray system, digital
Definium Pace Select ET System UDI
GE Hualun Medical Systems Co., Ltd
Pace Select ET
In Commercial Distribution

  • 00195278913807 ()


  • Stationary basic diagnostic x-ray system, digital
The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC70
In Commercial Distribution

  • 08806088670560 ()


  • Stationary basic diagnostic x-ray system, digital
The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM85
In Commercial Distribution

  • 08806088582412 ()


  • Mobile basic diagnostic x-ray system, digital
The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A
In Commercial Distribution

  • 08806088566313 ()


  • Stationary basic diagnostic x-ray system, digital
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC85A
In Commercial Distribution

  • 08806088565231 ()


  • Stationary basic diagnostic x-ray system, digital
The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A-65
In Commercial Distribution

  • 08806088520971 ()


  • Stationary basic diagnostic x-ray system, digital
The GM60A-32S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-32S
In Commercial Distribution

  • 08806088511153 ()


  • Mobile basic diagnostic x-ray system, digital
The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50A
In Commercial Distribution

  • 08806088351889 ()


  • Stationary basic diagnostic x-ray system, digital
The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50
In Commercial Distribution

  • 08806088351872 ()


  • Stationary basic diagnostic x-ray system, digital
The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-40S
In Commercial Distribution

  • 08806088088266 ()


  • Mobile basic diagnostic x-ray system, digital
The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC80
In Commercial Distribution

  • 08806086403467 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
GE MEDICAL SYSTEMS, INC.
5000
In Commercial Distribution

  • 00840682104364 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
GE MEDICAL SYSTEMS, INC.
XR240amx HD Upgrade Gen2
In Commercial Distribution

  • 00840682145749 ()


  • Mobile basic diagnostic x-ray system, digital
XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00840682142168 ()


  • Stationary basic diagnostic x-ray system, digital
Optima XR646 HD System
GE Hualun Medical Systems Co., Ltd
XR646 HD
In Commercial Distribution

  • 00840682142175 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
GE MEDICAL SYSTEMS, INC.
XR240amx HD Upgrade
In Commercial Distribution

  • 00840682123686 ()


  • Mobile basic diagnostic x-ray system, digital
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