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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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14.4v Battery Pack Assembly
Insurgical, Inc.
300-3002-001
In Commercial Distribution

  • 00860007230073 ()
3003022

  • Portable/mobile rechargeable battery pack
2.0 - 3.2 Pin Driver Assembly
Insurgical, Inc.
320-0070-001
In Commercial Distribution

  • 00860007230066 ()
9250022

  • Pin-driving power tool attachment
3.2 - 4.0 Pin Driver Assembly
Insurgical, Inc.
320-0107-001
In Commercial Distribution

  • 00860007230059 ()
9250023

  • Pin-driving power tool attachment
Jacobs chuck .25
Insurgical, Inc.
670-0003-001
In Commercial Distribution

  • 00860007230042 ()
9250012

  • Surgical drill chuck
Oscillating Saw Packaged Assembly
Insurgical, Inc.
320-0067-001
In Commercial Distribution

  • 00860007230035 ()
3010002

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Reciprocating Saw Packaged Assembly
Insurgical, Inc.
320-0071-001
In Commercial Distribution

  • 00860007230028 ()
3010003

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Drill-Reamer Packaged Assembly
Insurgical, Inc.
320-0064-001
In Commercial Distribution

  • 00860007230004 ()
3010001

  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use
TRAQinform Reports is a 100% software medical device data system that provides users with the means to select, render and modify layouts of static and interactive reports. TRAQinform Reports does not perform any image analysis or image processing of medical images. The device provides features to render available data components to formatted PDF, web pages, or text files.
Aiq Global, Inc.
1
In Commercial Distribution

  • 00860007104947 ()


  • Radiology information system application software
The TRAQinform Preprocessor is a 100% software medical device data system that provides users with the means to filter, perform quality checks, organize, and convert images from DICOM into other file formats including but not limited to Nearly Raw Raster Data (NRRD) format.
Aiq Global, Inc.
1
In Commercial Distribution

  • 00860007104923 ()


  • Radiology information system application software
Lowest level of use. Single Patient Multiple Use
Edzway LLC
IVY LOC
In Commercial Distribution

  • 00860007083105 ()
  • 00860007083112 ()
IVY001

  • Medical/surgical interventional tube/cable securement clip, single-use
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