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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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Assure - D798APP0

Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive

MC2 App - 00860008892744

No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital

N/A - 00840329814359

INJECTION GUN FOR MONOJECT TOOMEY 60CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89IGS-60CC
In Commercial Distribution

  • 00840329814359 ()
B89IGS-60CC

  • Syringe autofill kit

N/A - 00840329814342

INJECTION GUN SET, FOR 3CC, 5CC, 10CC BD SYRINGE
BLACK & BLACK SURGICAL, INC.
B89IGS-3510CC
In Commercial Distribution

  • 00840329814342 ()
B89IGS-3510CC

  • Syringe autofill kit

Auto-Fill® syringe kit - M20676000

The AUTO-FILL Syringe Kit is indicated for introduction of dilute lidocaine solutions into the subcutaneous tissue for the purposes of local anesthesia.
Vascular Solutions, Inc.
7600
Not in Commercial Distribution

  • M20676000 ()
  • M20676001 ()


  • Syringe autofill kit

StealthStation Cranial Software - 00643169865341

SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system

Rexton - 05714880113204

APP REXTON
Ws Audiology Usa, Inc.
Rexton App
In Commercial Distribution

  • 05714880113204 ()
10996567

  • Hearing aid/implant system remote control

AudioService - 05714880113198

APP AUDIOSERVICE
Ws Audiology Usa, Inc.
AudioService App
In Commercial Distribution

  • 05714880113198 ()
10996566

  • Hearing aid/implant system remote control

myRemote - 05714880113181

APP MYREMOTE
Ws Audiology Usa, Inc.
myRemote App
In Commercial Distribution

  • 05714880113181 ()
10996565

  • Hearing aid/implant system remote control

Vibe - 05714880113174

APP VIBE
Ws Audiology Usa, Inc.
Vibe App
In Commercial Distribution

  • 05714880113174 ()
10996564

  • Hearing aid/implant system remote control
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