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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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Nio Color 3MP - 05415334001695

MDNC-3421 HLX
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001695 ()
K9300345A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP - 05415334001688

MDNC-3421 DE NC
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001688 ()
K9300344A

  • Radiology picture archiving and communication system workstation

Coronis 5MP Mammo - 05415334001589

No Description
Barco NV
MDMG-5121
Not in Commercial Distribution

  • 05415334001589 ()
K9300508A

  • Radiology picture archiving and communication system workstation

Barco Mammo Tomosynthesis - 05415334001572

MDMG-5221 CB
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001572 ()
K9300521B

  • Radiology picture archiving and communication system workstation

Barco Mammo Tomosynthesis - 05415334001565

MDMG-5221
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001565 ()
K9300520B

  • Radiology picture archiving and communication system workstation

Coronis 5MP - 05415334001558

No Description
Barco NV
MDCG-5121
Not in Commercial Distribution

  • 05415334001558 ()
K9301500B

  • Radiology picture archiving and communication system workstation

Barco Mammo Tomosynthesis - 05415334001534

MDMG-5221 CB
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001534 ()
K9300521A

  • Radiology picture archiving and communication system workstation

Barco Mammo Tomosynthesis - 05415334001527

MDMG-5221 BB
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001527 ()
K9300520A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 4MP - 05415334001510

No Description
Barco NV
MDCC-4130
Not in Commercial Distribution

  • 05415334001510 ()
K9301605A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 10MP - 05415334001497

No Description
Barco NV
MDCG-10130
Not in Commercial Distribution

  • 05415334001497 ()
K9301660A

  • Radiology picture archiving and communication system workstation
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