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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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SleepRight - 00692121035216

SleepRight ProRx Custom-Fit Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Splintek Inc.
ProRx
In Commercial Distribution

  • 00692121035216 ()


  • Custom-made mouthguard

Aquilo Sports - 00850009827319

No Description
Aquilo Sports L.L.C.
CT1000 System
In Commercial Distribution

  • 00850009827319 ()


  • Circulating-fluid localized thermal therapy system

Aquilo Sports - 00850009827333

No Description
Aquilo Sports L.L.C.
CCT1500 System
In Commercial Distribution

  • 00850009827333 ()


  • Circulating-fluid localized thermal/compression therapy system control unit

EXTREME SPORTS - 10190886033616

ELASTICS AMBER HEAVY 3/8 5000/PK
G & H Wire Company, Inc.
M931-15
In Commercial Distribution

  • 20190886033613 ()
  • 10190886033616 ()
  • 00190886033619 ()


  • Orthodontic inter-arch elastic band

EXTREME SPORTS - 10190886033609

ELASTICS AMBER HEAVY 5/16 5000/PK
G & H Wire Company, Inc.
M931-14
In Commercial Distribution

  • 20190886033606 ()
  • 10190886033609 ()
  • 00190886033602 ()


  • Orthodontic inter-arch elastic band

EXTREME SPORTS - 10190886033593

ELASTICS AMBER HEAVY 1/4 5000/PK
G & H Wire Company, Inc.
M931-13
In Commercial Distribution

  • 20190886033590 ()
  • 10190886033593 ()
  • 00190886033596 ()


  • Orthodontic inter-arch elastic band

EXTREME SPORTS - 10190886033586

ELASTICS AMBER HEAVY 3/16 5000/PK
G & H Wire Company, Inc.
M931-12
In Commercial Distribution

  • 20190886033583 ()
  • 10190886033586 ()
  • 00190886033589 ()


  • Orthodontic inter-arch elastic band

EXTREME SPORTS - 10190886033579

ELASTICS AMBER HEAVY 1/8 5000/PK
G & H Wire Company, Inc.
M931-11
In Commercial Distribution

  • 20190886033576 ()
  • 10190886033579 ()
  • 00190886033572 ()


  • Orthodontic inter-arch elastic band

EXTREME SPORTS - 10190886033562

ELASTICS AMBER MEDIUM 3/8 5000/PK
G & H Wire Company, Inc.
M931-10
In Commercial Distribution

  • 20190886033569 ()
  • 10190886033562 ()
  • 00190886033565 ()


  • Orthodontic inter-arch elastic band

EXTREME SPORTS - 10190886033555

ELASTICS AMBER MEDIUM 5/16 5000/PK
G & H Wire Company, Inc.
M931-09
In Commercial Distribution

  • 20190886033552 ()
  • 10190886033555 ()
  • 00190886033558 ()


  • Orthodontic inter-arch elastic band
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