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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

Orthex External Fixation System - 00840194466103

Ex-Fix Hardware Removal, Tray
ORTHOPEDIATRICS CORP.
01-2200-0202
In Commercial Distribution

  • 00840194466103 ()
01-2200-0202

  • Instrument tray, reusable

Orthex External Fixation System - 00840194466097

Ex-Fix Hardware Removal, Case
ORTHOPEDIATRICS CORP.
01-2200-0201
In Commercial Distribution

  • 00840194466097 ()
01-2200-0201

  • Instrument tray, reusable

Surelock - 00840252901096

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

  • 00840252901096 ()
50218

  • Wheelchair/chair/stander headrest

Multi-Axis - 00840252901089

HEADREST HARDWARE, MULTI-AXIS OFFSET.
Therafin Corporation
50215
In Commercial Distribution

  • 00840252901089 ()
50215

  • Wheelchair/chair/stander headrest

GALILEOS - E27664488770

GALILEOS Hardware Comfort PLUS
SIRONA Dental Systems GmbH
6448877
Not in Commercial Distribution

  • E27664488770 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

GALILEOS - E27662999990

GALILEOS Hardware Comfort PLUS
SIRONA Dental Systems GmbH
6299999
Not in Commercial Distribution

  • E27662999990 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

CARDINAL HEALTH - 10887488156910

STERILE HARDWARE REMOVAL PACK
Cardinal Health 200, LLC
SOP81HRNEF
In Commercial Distribution

  • 50887488156918 ()
  • 10887488156910 ()
SOP81HRNEF

  • Orthopaedic surgical procedure kit, non-medicated, single-use

ITD - 00840178701466

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

  • 00840178701466 ()


  • Electromechanical device/system transport trolley

AADCO - 00840348505085

PIVOT BLOCKS WITH HARDWARE
AADCO MEDICAL, INC.
OSP-800PB
In Commercial Distribution

  • 00840348505085 ()
OSP-800PB

  • Custom-made medical device mount

Arial - 00840948100888

ASSY, FINAL, WAVEWARE+HARDWARE
Securitas Healthcare LLC
0900-353
In Commercial Distribution

  • 00840948100888 ()
0900-353

  • Phone/pager

Avalign - 00190776023492

Accessory Box w/hardware
Avalign Technologies, Inc.
NXS10011
In Commercial Distribution

  • 00190776023492 ()

  • Length: 1 Inch
  • Length: 3.5 Inch
  • Width: 1.5 Inch


  • Device sterilization/disinfection container, reusable

Avalign - 00190776023249

Accessory Box without hardware
Avalign Technologies, Inc.
G-ACCBX
In Commercial Distribution

  • 00190776023249 ()

  • Length: 1 Inch
  • Length: 3 Millimeter
  • Width: 1.5 Millimeter


  • Device sterilization/disinfection container, reusable

Avalign - 00190776022846

Accessory Box w/hardware
Avalign Technologies, Inc.
2133-03
In Commercial Distribution

  • 00190776022846 ()

  • Width: 1.5 Inch
  • Length: 3.5 Inch
  • Length: 1 Inch


  • Device sterilization/disinfection container, reusable

Avalign - 00190776022617

Accessory Box without hardware
Avalign Technologies, Inc.
2000-100-016
In Commercial Distribution

  • 00190776022617 ()

  • Length: 3.5 Inch
  • Length: 1.5 Inch
  • Width: 3.5 Inch


  • Device sterilization/disinfection container, reusable

Avalign - 00190776021931

Accessory Box w/hardware
Avalign Technologies, Inc.
SCS21000
In Commercial Distribution

  • 00190776021931 ()

  • Width: 1.5 Inch
  • Length: 1 Inch
  • Length: 3.5 Inch


  • Device sterilization/disinfection container, reusable

Avalign - 00190776020934

Accessory Box with hardware
Avalign Technologies, Inc.
113-114
In Commercial Distribution

  • 00190776020934 ()

  • Length: 3.5 Inch
  • Length: 1 Inch
  • Width: 1.5 Inch


  • Device sterilization/disinfection container, reusable

Avalign - 00190776020712

Accessory Box with hardware
Avalign Technologies, Inc.
1000-1120-017
In Commercial Distribution

  • 00190776020712 ()

  • Width: 1.5 Inch
  • Length: 3.5 Inch
  • Length: 1 Inch


  • Device sterilization/disinfection container, reusable

Avalign - 00190776020125

Accessory Box with hardware
Avalign Technologies, Inc.
2000-100-036
In Commercial Distribution

  • 00190776020125 ()

  • Width: 1.5 Inch
  • Length: 3.5 Inch
  • Length: 1 Inch


  • Device sterilization/disinfection container, reusable

Millennium - 00190776115708

Accessory Box no hardware
Avalign Technologies, Inc.
2000-100-016
In Commercial Distribution

  • 00190776115708 ()


  • Device sterilization/disinfection container, reusable
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