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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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ACIST HDi® HD IVUS System - 40841716102101

ACI Hardware, HDi System p/n 801085-001 Contents: ACI Hardware
ACIST MEDICAL SYSTEMS, INC.
016375
In Commercial Distribution

  • 40841716102101 ()


  • Cardiovascular ultrasound imaging system

MAX Coil S - 09008737092726

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09272
In Commercial Distribution

  • 09008737092726 ()


  • Hearing implant implantable-component tester, postoperative

MAX Coil - 09008737092719

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09271
In Commercial Distribution

  • 09008737092719 ()


  • Hearing implant implantable-component tester, postoperative

DIB II Coil i100 - 09008737043766

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
04376
Not in Commercial Distribution

  • 09008737043766 ()


  • Hearing implant implantable-component tester, postoperative

DIB II Coil - 09008737041434

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
04143
Not in Commercial Distribution

  • 09008737041434 ()


  • Hearing implant implantable-component tester, postoperative

E-Sphyg™ II - 00634782057909

Mounting Plate-9002,w/hardware
AMERICAN DIAGNOSTIC CORP
9002-6
In Commercial Distribution

  • 00634782057909 ()
9002-6

  • Blood pressure cuff, reusable

Specialty Instrument, Hardware Removal Caddy - 00889795141590

Hardware Removal Caddy, Lid
Paragon 28, Inc.
SP99-LID-0001
In Commercial Distribution

  • 00889795141590 ()
SP99-LID-0001

  • Device sterilization/disinfection container, reusable

Specialty Instrument, Hardware Removal Caddy - 00889795141583

Hardware Removal Caddy, Base
Paragon 28, Inc.
SP99-CAD-0001
In Commercial Distribution

  • 00889795141583 ()
SP99-CAD-0001

  • Device sterilization/disinfection container, reusable

ITD - 00840178701466

Wire basket with hardware
Touchpoint Medical, Inc.
CD.06085.799
In Commercial Distribution

  • 00840178701466 ()


  • Electromechanical device/system transport trolley

Surelock - 00840252901096

HEADREST HARDWARE, SURELOCK MULTI-AXIS.
Therafin Corporation
50218
In Commercial Distribution

  • 00840252901096 ()
50218

  • Wheelchair/chair/stander headrest
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