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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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Aero-Med - 10810010890495

ThinPrep Collection Tools; Broom
AERO-MED, LLC
BRL190
In Commercial Distribution

  • 50810010890493 ()
  • 10810010890495 ()
BRL190

  • Cervical cytology brush

Aero-Med - 10810010890471

SurePath Collection Tools; Combo
AERO-MED, LLC
BRL165
In Commercial Distribution

  • 50810010890479 ()
  • 10810010890471 ()
BRL165

  • Papanicolaou smear kit

Aero-Med - 10810010890464

SurePath Collection Tools; Broom
AERO-MED, LLC
BRL150
In Commercial Distribution

  • 50810010890462 ()
  • 10810010890464 ()
BRL150

  • Cervical cytology brush

DTI IMPLANT SISTEMLERI - 08680671496399

REMOVAL TOOLS ULTRA MINI
DTI IMPLANT SISTEMLERI SANAYI TICARET ANONIM SIRKETI
SURGICAL KIT
In Commercial Distribution

  • 08680671496399 ()
DTIDRTOUM

  • Surgical screwdriver, reusable

NA - 10681490078013

ACCESSORY 3550-06 TUNNELING TOOLS
MEDTRONIC, INC.
3550-06
Not in Commercial Distribution

  • 10681490078013 ()


  • Subcutaneous tunneller, single-use

Tsolution One Surgical System - M9461029400

ASSEMBLY, INSTALLATION VERIFICATION TOOLS
THINK SURGICAL, INC.
102940
In Commercial Distribution

  • M9461029400 ()


  • Robotic surgical arm system

VT1 - 03760253450577

No Description
FIM MEDICAL
Software
In Commercial Distribution

  • 03760253450577 ()


  • Pulmonary function analysis system, adult

VT1 - 03760253450157

No Description
FIM MEDICAL
Software
Not in Commercial Distribution

  • 03760253450157 ()


  • Pulmonary function analysis system, adult

T.O.V.A. - 00862290000326

The Test of Variables of Attention (T.O.V.A.) software is a computerized assessment of attention and inhibitory control that runs on most Windows and Mac-based computers. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Software
In Commercial Distribution

  • 00862290000326 ()


  • Cognitive assessment software

NIDO Pedicle Screw System - B07315K0430210

Sagittal Bender, Double Ended Right
Kalitec Direct LLC
15-K04-3021
In Commercial Distribution

  • B07315K0430210 ()
15-K04-3021

  • Spinal rod bending system
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