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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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Fetal Monitor Remote Display - B321340226010

No Description
CLINICOMP INTERNATIONAL, INC.
FMRD 4K 55"
In Commercial Distribution

  • B321340226010 ()

  • Height: 28 Inch
  • Length: 49 Inch
  • Weight: 42 Pound
340-22601

  • Centralized patient monitor

Aadva™ - J0229405021

Aadva™ IOS 100: IOS cart, IOS Handpiece (via USB connection), CPU (onboard computer), G.U.I. touchscreen, holder inserts bags of 10, plug, IFUs (includes: Quick Start Guide & Owners manual).
Gc America Inc.
940502
In Commercial Distribution

  • J0229405021 ()
940502

  • Dental milling system, CAD/CAM, laboratory

Ambra Health Mobile Application - AMBRMOBILEAPP0

Mobile Application version of Ambra Health. Not intended for diagnostic purposes.
Ambra Health
AMBRMOBILEAPP0
In Commercial Distribution

  • AMBRMOBILEAPP0 ()


  • Radiology information system

Ambra PACS - AMBRHEALTHSOLUTIONS0

No Description
Ambra Health
3.16.10.0
In Commercial Distribution

  • AMBRHEALTHSOLUTIONS0 ()


  • Radiology information system

Ambra PACS - AMBRAPACS0

No Description
Ambra Health
3.24
In Commercial Distribution

  • AMBRAPACS0 ()


  • Radiology information system

Footctrl - J00716006310011

Used to control the console used in dentistry for implantology, dental surgery and endodontic work.
Bien-Air Dental SA
1600631-001
In Commercial Distribution

  • J00716006310011 ()
1600631-001

  • Foot-switch, electrical
  • Surgical power tool system control unit, line-powered

WIRELESS FOOTCTRL + DONGLE - J00716011920011

Used to controle the console used in dentistry for implantology, dental surgery and endodontic work.
Bien-Air Dental SA
1601192-001
In Commercial Distribution

  • J00716011920011 ()
1601192-001

  • Foot-switch, electrical
  • Surgical power tool system control unit, line-powered

Lifecare PCA - M3352083704021

PCA 7.X w/ MedNet
ICU MEDICAL, INC.
208370402
In Commercial Distribution

  • M3352083704021 ()

  • Height: 15.875 Inch
  • Length: 13.125 Inch
  • Depth: 11.75 Inch
20837

  • Patient-controlled analgesia infusion pump

Lifecare PCA - M3352083704011

PCA 7.X w/ MedNet
HOSPIRA, INC.
20837
In Commercial Distribution

  • M3352083704011 ()

  • Height: 15.875 Inch
  • Length: 13.125 Inch
  • Depth: 11.75 Inch
20837

  • Patient-controlled analgesia infusion pump

Accuro - B015000010

No Description
RIVANNA MEDICAL, LLC
00001
In Commercial Distribution

  • B015000010 ()
  • B015000011 ()


  • Hand-held ultrasound imaging system, body-surface
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