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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No Description
CHURCH & DWIGHT CO., INC.
00022600937524
In Commercial Distribution

  • 00022600937524 ()
  • 80022600937520 ()


  • Basic male condom, Hevea-latex
Bertec Balance Advantage Head Mounted Display (HMD) system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Head Mounted Display (HMD) to enhance clinical balance assessment and training.
BERTEC CORPORATION
97P-0109
In Commercial Distribution

  • 00850017250116 ()


  • Biomechanical function analysis/rehabilitation software
  • Posturography system
Single-lead ECG monitor intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation.
FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED
Frontier X Plus
In Commercial Distribution

  • 08908013617128 ()


  • Electrocardiographic long-term ambulatory recording analyser
  • Telemetric electrocardiographic ambulatory recorder
  • Electrocardiograph, home-use
PACKAGE, LIFECARD CF AND PATHFINDER SL
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifecard
In Commercial Distribution

  • 10841522127212 ()
040-1760-00

  • Electrocardiographic ambulatory recorder
  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
No Description
CHURCH & DWIGHT CO., INC.
00022600973270
In Commercial Distribution

  • 00022600973270 ()
  • 80022600973276 ()


  • Basic male condom, Hevea-latex
No Description
CHURCH & DWIGHT CO., INC.
00022600974529
In Commercial Distribution

  • 00022600974529 ()
  • 80022600974525 ()


  • Medicated male condom, Hevea-latex
The MERIDIAN Disposable Electrode Patch consists of four patches, two for the mother’s abdomen and one for each of her sides, which provides continuous fetal signal capture during fetal movement.
MINDCHILD MEDICAL
MDPA1
In Commercial Distribution

  • 00867696000345 ()
  • 00867696000338 ()
  • 00867696000321 ()


  • Electrocardiographic electrode, single-use
The Opera+ is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast
UNIMOM CO.
Opera+
In Commercial Distribution

  • 08809224872460 ()


  • Breast pump, electric
The Opera is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast
UNIMOM CO.
Opera
In Commercial Distribution

  • 08809224872262 ()


  • Breast pump, electric
The Minuet LCD+ is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast
UNIMOM CO.
Minuet LCD+
In Commercial Distribution

  • 08809224872408 ()


  • Breast pump, electric
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