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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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APP PAD W/HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002F
In Commercial Distribution

  • 30815067042556 ()
  • 00081506704258 ()


  • Alternating-pressure bed mattress overlay, reusable
18X24CM DRCTVIEW HR SP APP SCRN
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with HR Screen
In Commercial Distribution

  • 60889971044617 ()
  • 40889971044613 ()
1044619

  • Digital imaging cassette/phosphor plate
IMAGE SUITE / V4 SW MEDICAL APP
CARESTREAM HEALTH, INC.
CARESTREAM Image Suite
In Commercial Distribution

  • 60889971055989 ()
1055987

  • Radiological PACS software
LUX-Dx Clinic Assistant app (Mobile application)
BOSTON SCIENTIFIC CORPORATION
622935-100
In Commercial Distribution

  • 00802526607615 ()
622935-100

  • Implantable cardiac device management application software
LARGE VESS APP 15MM TAPERED BLADES
TELEFLEX INCORPORATED
IPN002336
In Commercial Distribution

  • 04026704507108 ()
  • 24026704507102 ()

  • Length: 1.625 Inch
  • Width: 1 Inch
065196

  • Surgical bulldog clamp, reusable
Omnipod Display is secondary display app
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120265 ()
18239

  • Ambulatory insulin infusion pump software, data-display
The Reliance Endoscope Transport cart is designed to safely and easily transport endoscopes to a procedure room or to reprocessing.
Corporation Steris Canada
RETCART01
Not in Commercial Distribution

  • 00724995197711 ()
RETCART01

  • Surgical/procedural instrument transport cabinet
Used to carry the implant from the package to the surgical site and to drive the implant into the bone.
STERNGOLD DENTAL LLC
905286
In Commercial Distribution

  • 00841549118098 ()


  • Surgical screwdriver, reusable
Used to carry the implant from the package to the surgical site and to drive the implant into the bone.
STERNGOLD DENTAL LLC
905285
In Commercial Distribution

  • 00841549118081 ()


  • Surgical screwdriver, reusable
Height adjustable arm grounded, VESA 75/75, attached to vertical pole to be mouted to, horizontal rail, spring strength 600N
CIM med GmbH
PH-431C-TSM.gr1_60
In Commercial Distribution

  • 04061162104346 ()


  • Medical monitor/light mount
Height adjustable arm grounded, VESA 75/75, attached to vertical pole to be mouted to horizontal rail, spring strength 240N
CIM med GmbH
PH-431C-TSM.gr1_24
In Commercial Distribution

  • 04061162009931 ()


  • Medical monitor/light mount
To prepare physicians and dental practices with advanced cardiac life support medications to respond to medical emergencies until EMS arrives.
HF ACQUISITION CO. LLC
1003471
Not in Commercial Distribution

  • 00850065007342 ()
1003471

  • First aid kit, medicated
An x-ray system component intended to be mounted to the floor, to support and facilitate position of the x-ray tube.
Del Medical, Inc.
FMT
In Commercial Distribution

  • 00858340006318 ()


  • X-ray system tube support, floor standing
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel-CSP Sahara
In Commercial Distribution

  • EBCI5201PRO0 ()

  • Channel Number 32
5201PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel
In Commercial Distribution

  • EBCI5110PRO0 ()

  • Channel Number 16
5110PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel
In Commercial Distribution

  • EBCI5100PRO0 ()

  • Channel Number 32
5100PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
19 FLEXIBLE channels
In Commercial Distribution

  • EBCI5730PRO0 ()
5730PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
8 FLEXIBLE channels
In Commercial Distribution

  • EBCI5720PRO0 ()
5720PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16 FLEXIBLE channels
In Commercial Distribution

  • EBCI5710PRO0 ()
5710PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32 FLEXIBLE channels
In Commercial Distribution

  • EBCI5700PRO0 ()
5700PRO

  • Multiple physiological signal amplifier
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