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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No Description
Biomet Orthopedics, LLC
32-467043
In Commercial Distribution

  • 00880304337787 ()
32-467043

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-467040
In Commercial Distribution

  • 00880304337756 ()
32-467040

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-467038
In Commercial Distribution

  • 00880304337732 ()
32-467038

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-467037
In Commercial Distribution

  • 00880304337725 ()
32-467037

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-467035
In Commercial Distribution

  • 00880304337701 ()
32-467035

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-467033
In Commercial Distribution

  • 00880304337688 ()
32-467033

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-467032
In Commercial Distribution

  • 00880304337671 ()
32-467032

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
31-473621
In Commercial Distribution

  • 00880304315006 ()
31-473621

  • Surgical mallet
No Description
Biomet Orthopedics, LLC
909874
In Commercial Distribution

  • 00880304863422 ()

  • 4.5 MM
909874

  • Ligament bone anchor
Face Shield with Replacement Visors class II (Face Shield 10 pieces +
Pajunk GmbH Medizintechnologie
Z9070013
Not in Commercial Distribution

  • 04048223041611 ()
  • 14048223041618 ()
Z9070013

  • Face splash shield, single-use
Face Shield with Replacement Visors (Face Shield 10 pieces + Replacement Visors 20 pieces )
Pajunk GmbH Medizintechnologie
Z9070011
Not in Commercial Distribution

  • 04048223041482 ()
  • 14048223041489 ()
Z9070011

  • Face splash shield, single-use
BATTERY, LI-ION, LP35
PHYSIO-CONTROL, INC.
11335
In Commercial Distribution

  • 00883873790144 ()
11335-000001

  • Portable/mobile rechargeable battery pack
No Description
CHARMANT INC.
37-0057
In Commercial Distribution

  • 00883475952162 ()


  • Suturing needle holder, reusable
Femoral Stem Impactor with Anteversion
TOTAL JOINT ORTHOPEDICS, INC.
1307.00.000
In Commercial Distribution

  • 00819251021197 ()


  • Orthopaedic implant impactor, reusable
No Description
Biomet Orthopedics, LLC
909849
In Commercial Distribution

  • 00880304979598 ()
909849

  • Ligament reconstruction instrument set, reusable
No Description
Biomet Orthopedics, LLC
909848
In Commercial Distribution

  • 00880304979581 ()
909848

  • Ligament reconstruction instrument set, reusable
Product Box also contain OS-SPA DI 00850391007146
ABYRX, INC.
OS-101
In Commercial Distribution

  • 00850391007160 ()
  • 00850391007139 ()


  • Bone wax, synthetic
Product Box also contains OS-SPA DI 00850391007146
ABYRX, INC.
OS-201
In Commercial Distribution

  • 00850391007153 ()
  • 00850391007023 ()


  • Bone wax, synthetic
Seamfree Single Syringe with Tips
Vista Dental
1
In Commercial Distribution

  • 00850194007336 ()
104-01

  • Dental restorative unfilled resin kit, standard
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
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
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD030US
Not in Commercial Distribution

  • 00851861007246 ()

  • Circumference: 200 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD000US
Not in Commercial Distribution

  • 00851861007222 ()

  • Circumference: 200 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis
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
Mobile Touch Dock with battery. Includes Power Cable Holder
Bk Medical ApS
UA1814
Not in Commercial Distribution

  • 05704916001087 ()


  • General-purpose ultrasound imaging system
Mobile Keyboard Dock with backpack and battery. Includes Power Cable Holder
Bk Medical ApS
UA1214
Not in Commercial Distribution

  • 05704916001056 ()


  • General-purpose ultrasound imaging system
No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003458 ()


  • Percutaneous electrical stimulation lead external pulse generator cable, reusable
No Description
Merit Pharmaceutical
036319571000
In Commercial Distribution

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


  • Basic intravenous administration set, noninvasive
Oral/Nasal w/filter (50)
Ambu A/S
814320-000/50
In Commercial Distribution

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

  • Polysomnograph
Acessa ProVu Transducer with sensor, Reusable, connects to the Acessa ProVu Console
ACESSA HEALTH INC.
7700
In Commercial Distribution

  • 00854763006188 ()


  • Surgical ultrasound imaging transducer
Siliclone X-Act with 4 Tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788009 ()
10112

  • Earmould impression material
The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be attached to an IV Pole with the pole-clamp and knob.
POTRERO MEDICAL, INC.
FGN-06-100202
In Commercial Distribution

  • 00850019755237 ()
FGN-06-100202

  • Portable active medical device mount
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