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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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Archimedies Access Kit with Syringe - 00856571007234

A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
BRONCUS MEDICAL INC.
12196-09
In Commercial Distribution

  • 00856571007234 ()
10009-09

  • Lung biopsy procedure kit

Pleuraflow® System with FlowGlide - 00856449006260

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

Pleuraflow® System with FlowGlide - 00856449006253

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

Pleuraflow® System with FlowGlide - 00856449006246

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

Pleuraflow® System with FlowGlide - 00856449006239

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

Pleuraflow® System with FlowGlide - 00856449006222

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

Pleuraflow® System with FlowGlide - 00856449006208

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

Pleuraflow® System with FlowGlide - 00856449006192

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

Pleuraflow® System with FlowGlide - 00856449006185

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

Pleuraflow® System with FlowGlide - 00856449006178

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

PleuraFlow® System with FlowGlide - 00856449006147

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

PleuraFlow® System with FlowGlide - 00856449006123

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

PleuraFlow® System with FlowGlide - 00856449006116

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

PleuraFlow® System with FlowGlide - 00856449006109

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

PleuraFlow® System with FlowGlide - 00856449006093

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

PleuraFlow® System with FlowGlide - 00856449006086

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

PleuraFlow® System with FlowGlide - 00856449006079

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

PleuraFlow® System with FlowGlide - 00856449006062

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

PleuraFlow® System with FlowGlide - 00856449006055

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

PleuraFlow® System with FlowGlide - 00856449006048

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 - 00855997006890

DermLite Foto X with Nailio
DermLite LLC
DLFX-NL1
In Commercial Distribution

  • 00855997006890 ()
DLFX-NL1

  • Dermatoscope, optical

Syndex with Constrictor® Technology - 00854629006727

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

Acessa ProVu Transducer with sensor - 00854763006188

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

  • 00854763006188 ()


  • Surgical ultrasound imaging transducer

ZipCombo Centrifuge with hematocrit rotor - 00664816001745

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

  • 00664816001745 ()


  • Microhaematocrit centrifuge IVD

BATTERY, LI-ION, WITH IFU, LP35 - 00883873790144

BATTERY, LI-ION, LP35
PHYSIO-CONTROL, INC.
11335
In Commercial Distribution

  • 00883873790144 ()
11335-000001

  • Portable/mobile rechargeable battery pack

Needle Holder with Lock(Slim) - 00883475952162

No Description
CHARMANT INC.
37-0057
In Commercial Distribution

  • 00883475952162 ()


  • Suturing needle holder, reusable

ToggleLoc™ With Ziploop™ - 00880304979598

No Description
Biomet Orthopedics, LLC
909849
In Commercial Distribution

  • 00880304979598 ()
909849

  • Ligament reconstruction instrument set, reusable

ToggleLoc™ With Ziploop™ - 00880304979581

No Description
Biomet Orthopedics, LLC
909848
In Commercial Distribution

  • 00880304979581 ()
909848

  • Ligament reconstruction instrument set, reusable

Passing Needle Kit with Obturator - 00841823100436

No Description
Ad-Tech Medical Instrument Corporation
APNK1-5.0X
In Commercial Distribution

  • 90841823100439 ()
  • 00841823100436 ()
APNK1-5.0X

  • Wire/ligature passer, reusable

Passing Needle Kit with Obturator - 00841823100429

No Description
Ad-Tech Medical Instrument Corporation
APNK1-3.5X
In Commercial Distribution

  • 90841823100422 ()
  • 00841823100429 ()
APNK1-3.5X

  • Wire/ligature passer, reusable
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