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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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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

DermLite Foto X with Nailio - 00855997006890

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

  • 00855997006890 ()
DLFX-NL1

  • Dermatoscope, optical

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

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

Mobile Touch Dock with battery - 05704916001087

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 battery - 05704916001056

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

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

IV Set With In-Line Filter - 00853620005203

No Description
Merit Pharmaceutical
036319571000
In Commercial Distribution

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


  • Basic intravenous administration set, noninvasive

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
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