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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PFFG3-32 RA Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-32 RA
In Commercial Distribution

  • 10856449006267 ()
  • 00856449006260 ()
  • 20856449006264 ()

  • Catheter Gauge: 32 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG3-28 RA Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-28 RA
In Commercial Distribution

  • 10856449006250 ()
  • 00856449006253 ()
  • 20856449006257 ()

  • Catheter Gauge: 28 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG3-24 RA Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-24 RA
In Commercial Distribution

  • 10856449006243 ()
  • 00856449006246 ()
  • 20856449006240 ()

  • Catheter Gauge: 24 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG3-24 XDL Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-24 XDL
In Commercial Distribution

  • 10856449006236 ()
  • 00856449006239 ()
  • 20856449006233 ()

  • Catheter Gauge: 24 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG3-20 XDL Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-20 XDL
In Commercial Distribution

  • 10856449006229 ()
  • 00856449006222 ()
  • 20856449006226 ()

  • Catheter Gauge: 20 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG3-32 Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-32
In Commercial Distribution

  • 10856449006205 ()
  • 00856449006208 ()
  • 20856449006202 ()

  • Catheter Gauge: 32 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG3-28 Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-28
In Commercial Distribution

  • 10856449006199 ()
  • 00856449006192 ()
  • 20856449006196 ()

  • Catheter Gauge: 28 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG3-24 Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-24
In Commercial Distribution

  • 10856449006182 ()
  • 00856449006185 ()
  • 20856449006189 ()

  • Catheter Gauge: 24 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG3-20 Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-20
In Commercial Distribution

  • 10856449006175 ()
  • 00856449006178 ()
  • 20856449006172 ()

  • Catheter Gauge: 20 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG-32 RA PleuraFlow® System with FlowGlide™
Clearflow, Inc.
PFFG-32 RA
In Commercial Distribution

  • 00856449006147 ()
  • 10856449006144 ()
  • 20856449006141 ()

  • Catheter Gauge: 32 French


  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter
  • Closed-wound drain, non-bioabsorbable
PFFG-28 RA PleuraFlow® System with FlowGlide
Clearflow, Inc.
PFFG-28 RA
In Commercial Distribution

  • 20856449006127 ()
  • 10856449006120 ()
  • 00856449006123 ()

  • Catheter Gauge: 28 French


  • Closed-wound drain, non-bioabsorbable
  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter
The SuperTrapeze is a high quality, commercial grade over-bed trapeze that connects to the SuperPole (floor to ceiling safety pole). The SuperTrapeze handle features two offset ladder rungs to allow for improved use of arm strength and increased comfort. Additionally, it can hook around the pole to store out of the way when not in use. The SuperTrapeze handle is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The SuperTrapeze handle is installed onto the SuperPole by securing a support arm to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the support arm in place, and the spring ring is used to prevent the set screws from back-threading. The support arm has an adjustable strap that attaches to the trapeze handle. The SuperTrapeze handle is strong enough to support the user when sitting up in bed and standing. It is important to set proper height and orientation of the SuperTrapeze to optimize the user’s range of motion. The maximum user weight for this product is 300lbs / 136kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
STP-S
In Commercial Distribution

  • 00689281020596 ()
02059

  • Hand rail
The MRI Stretcher with Fowler positioning is non-magnetic, all aluminum, and designed for heavy-duty use.
Mirion Technologies (capintec), Inc.
240-110
In Commercial Distribution

  • 00879942070767 ()
240-110

  • MRI system table, non-powered
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00150
Not in Commercial Distribution

  • 00873263001509 ()
FC1008

  • Neurosurgical micro targeting drive
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00144
Not in Commercial Distribution

  • 00873263001448 ()
FC1008

  • Neurosurgical micro targeting drive
microTargeting Controller with encoder option for use with STar and mT Drives
FHC, INC.
FC1007-00143
In Commercial Distribution

  • 00873263001431 ()
FC1007

  • Neurosurgical micro targeting drive
Hemorrhage Occluder Pin Large - 14 mm head
SURGIN SURGICAL INSTRUMENTATION, INC.
CR1014
In Commercial Distribution

  • 00868742000111 ()
  • 10868742000118 ()

  • Width: 14 Millimeter
CR1014

  • Haemorrhage control pin
Hemorrhage Occluder Pin Standard - 10 mm head
SURGIN SURGICAL INSTRUMENTATION, INC.
CR1007
In Commercial Distribution

  • 00868742000104 ()
  • 10868742000101 ()

  • Width: 10 Millimeter
CR1007

  • Haemorrhage control pin
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00826
In Commercial Distribution

  • 00873263008263 ()
FC1008

  • Neurosurgical micro targeting drive
Oral/Nasal w/filter (50)
Ambu A/S
814320-000/50
In Commercial Distribution

  • 05707480041848 ()
  • 05707480133918 ()
814320-000/50

  • Polysomnograph
ZipCombo Centrifuge, hematocrit rotor, capacity 12-40mm tubes
LW SCIENTIFIC, INC.
ZCC-12HD-40T3
In Commercial Distribution

  • 00664816001745 ()


  • Microhaematocrit centrifuge IVD
No Description
Merit Pharmaceutical
036319571000
In Commercial Distribution

  • 20853620005207 ()
  • 10853620005200 ()
  • 00853620005203 ()


  • Basic intravenous administration set, noninvasive
Acessa ProVu Transducer with sensor, Reusable, connects to the Acessa ProVu Console
ACESSA HEALTH INC.
7700
In Commercial Distribution

  • 00854763006188 ()


  • Surgical ultrasound imaging transducer
Syndex with Constrictor® Technology for Syndesmosis Repair
DUNAMIS MEDICAL, LLC
MSYN0000
In Commercial Distribution

  • 00854629006727 ()
MSYN0000

  • Orthopaedic fixation suture button
  • Fluted surgical drill bit, single-use
Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-500ML
In Commercial Distribution

  • 00857515006153 ()

  • Total Volume: 500 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
PFFG-24 RA PleuraFlow® System with FlowGlide
Clearflow, Inc.
PFFG-24 RA
In Commercial Distribution

  • 20856449006110 ()
  • 10856449006113 ()
  • 00856449006116 ()

  • Catheter Gauge: 24 French


  • Closed-wound drain, non-bioabsorbable
  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
PFFG-24 XDL PleuraFlow® System with FlowGlide
Clearflow, Inc.
PFFG-24 XDL
In Commercial Distribution

  • 20856449006103 ()
  • 10856449006106 ()
  • 00856449006109 ()

  • Catheter Gauge: 24 French


  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
  • Closed-wound drain, non-bioabsorbable
PFFG-20 XDL PleuraFlow® System with FlowGlide
Clearflow, Inc.
PFFG-20 XDL
In Commercial Distribution

  • 00856449006093 ()
  • 10856449006090 ()
  • 20856449006097 ()

  • Catheter Gauge: 20 French


  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter
  • Closed-wound drain, non-bioabsorbable
PFFG-32 PleuraFlow® System with FlowGlide™
Clearflow, Inc.
PFFG-32
In Commercial Distribution

  • 20856449006080 ()
  • 10856449006083 ()
  • 00856449006086 ()

  • Catheter Gauge: 32 French


  • Closed-wound drain, non-bioabsorbable
  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
PFFG-28 PleuraFlow® System with FlowGlide™
Clearflow, Inc.
PFFG-28
In Commercial Distribution

  • 20856449006073 ()
  • 10856449006076 ()
  • 00856449006079 ()

  • Catheter Gauge: 28 French


  • Closed-wound drain, non-bioabsorbable
  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter
PFFG-24 PleuraFlow® System with FlowGlide™
Clearflow, Inc.
PFFG-24
In Commercial Distribution

  • 20856449006066 ()
  • 10856449006069 ()
  • 00856449006062 ()

  • Catheter Gauge: 24 French


  • Closed-wound drain, non-bioabsorbable
  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
PFFG-20 PleuraFlow® System with FlowGlide™
Clearflow, Inc.
PFFG-20
In Commercial Distribution

  • 20856449006059 ()
  • 10856449006052 ()
  • 00856449006055 ()

  • Catheter Gauge: 20 French


  • Closed-wound drain, non-bioabsorbable
  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
PF-20 SEDL PleuraFlow® System with FlowGlide
Clearflow, Inc.
PF-20 SEDL
In Commercial Distribution

  • 10856449006045 ()
  • 00856449006048 ()
  • 20856449006042 ()

  • Catheter Gauge: 20 French


  • Closed-wound drain, non-bioabsorbable
  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
DermLite Foto X with Nailio
DermLite LLC
DLFX-NL1
In Commercial Distribution

  • 00855997006890 ()
DLFX-NL1

  • Dermatoscope, optical
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution

  • 00858012005878 ()
DSC014-03-US

  • Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005861 ()
D4D0192

  • Basic diagnostic x-ray system application software
DenteShield Sample Opaque with Fluoride
ELEVATE ORAL CARE, LLC
685DSSAMP
Not in Commercial Distribution

  • 00858290006598 ()


  • Dental unfilled resin sealant/coating
No Description
NINEPOINT MEDICAL, INC.
94301-MI
In Commercial Distribution

  • 00859591006249 ()
94301-MI

  • Endoscopic optical coherence tomography system
No Description
Biomet Orthopedics, LLC
32-467059
In Commercial Distribution

  • 00880304337947 ()
32-467059

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-467058
In Commercial Distribution

  • 00880304337930 ()
32-467058

  • Knee tibia prosthesis trial, reusable
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