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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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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

Hemasorb 1.0 gram with Spatula - 00850391007139

Product Box also contain OS-SPA DI 00850391007146
ABYRX, INC.
OS-101
In Commercial Distribution

  • 00850391007160 ()
  • 00850391007139 ()


  • Bone wax, synthetic

Hemasorb 2.0 gram with Spatula - 00850391007023

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 - 00850194007336

Seamfree Single Syringe with Tips
Vista Dental
1
In Commercial Distribution

  • 00850194007336 ()
104-01

  • Dental restorative unfilled resin kit, standard

Respire Pink EF+ with DentiTrac - 00851861007246

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

Respire Pink+ Hard with DentiTrac - 00851861007222

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

SleepmateOral/Nasal Cannula with filter - 05707480041848

Oral/Nasal w/filter (50)
Ambu A/S
814320-000/50
In Commercial Distribution

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

  • Polysomnograph

Surface Electrode, 4-pack with Interconnect - 00852184003458

No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003458 ()


  • Percutaneous electrical stimulation lead external pulse generator cable, reusable

Virtuosaph Plus with Radial Indication - 00699753450769

No Description
Terumo Cardiovascular Systems Corporation
VSP550EX
In Commercial Distribution

  • 50699753450764 ()
  • 00699753450769 ()


  • Endoscopic electrosurgical electrode, bipolar, single-use

Batrik Red Padlock with Indicator - 00690521015654

Padlock Security Tags with indicator
Batrik Medical Manufacturing Inc
15-814-IND
In Commercial Distribution

  • 00690521015654 ()
15-814-IND

  • Device operating status label/tag, single-use
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