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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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ZEISS Axiolab - 06909262200231

No Description
Carl Zeiss Suzhou Co., Ltd.
Axiolab 5
In Commercial Distribution

  • 06909262200231 ()
430037-9011-000

  • Basic light microscope

Fibrous 5 Diagnostic Ultrasound System - 06936415975173

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Fibrous 5
In Commercial Distribution

  • 06936415975173 ()


  • General-purpose ultrasound imaging system

Hepatus 5 Diagnostic Ultrasound System - 06936415970895

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Hepatus 5
In Commercial Distribution

  • 06936415970895 ()


  • General-purpose ultrasound imaging system

MR-RT - 00884838122123

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
RTgo 5
In Commercial Distribution

  • 00884838122123 ()
781439

  • MRI system application software

WOODPECKER - 06944843610047

Ultrasonic dental scaling/debridement system
Guilin Woodpecker Medical Instrument Co., Ltd.
PT 5
In Commercial Distribution

  • 06944843610047 ()


  • Ultrasonic dental scaling/debridement system

cvi42 - 00882916000011

No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution

  • 00882916000011 ()


  • MRI system application software

V.A.C.INSTILL® - 00878237001639

V.A.C. Instill Irrigation Set
KCI USA, INC.
M6275413/5
Not in Commercial Distribution

  • 00878237001639 ()
  • 00878237001417 ()


  • Negative-pressure wound therapy system pump, electric

V.A.C. ATS™ - 00878237001455

1000 ml canister (with Gel) for VAC ATS Therapy Systems
KCI USA, INC.
M6275093/5
Not in Commercial Distribution

  • 00878237001455 ()
  • 00878237001431 ()


  • Negative-pressure wound therapy system canister

V.A.C.® - 00878237001325

Vac Abdominal Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275080/5
In Commercial Distribution

  • 00878237001325 ()


  • Negative-pressure wound therapy open-abdomen dressing

V.A.C. ® GRANUFOAM™ - 00878237001127

Vac Granufoam Heel Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275074/5
In Commercial Distribution

  • 00878237001127 ()
  • 00878237001110 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
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