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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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Batrik Blue Padlock with Indicator - 00690521005310

Padlock Security Tags with indicator
Batrik Medical Manufacturing Inc
15-720-IND
In Commercial Distribution

  • 00690521005310 ()
15-720-IND

  • Device operating status label/tag, single-use

Batrik Black Padlock with Indicator - 00690521005297

Padlock Security Tags with indicator
Batrik Medical Manufacturing Inc
15-719-IND
In Commercial Distribution

  • 00690521005297 ()
15-719-IND

  • Device operating status label/tag, single-use

Batrik Orange Padlock with Indicator - 00690521005273

Padlock Security Tags with indicator
Batrik Medical Manufacturing Inc
15-717-IND
In Commercial Distribution

  • 00690521005273 ()
15-717-IND

  • Device operating status label/tag, single-use

Batrik Yellow Padlock with Indicator - 00690521005235

Padlock Security Tags with indicator
Batrik Medical Manufacturing Inc
15-715-IND
In Commercial Distribution

  • 00690521005235 ()
15-715-IND

  • Device operating status label/tag, single-use

Batrik Red Padlock with Indicator - 00690521005211

Padlock Security Tags with indicator
Batrik Medical Manufacturing Inc
15-714-IND
In Commercial Distribution

  • 00690521005211 ()
15-714-IND

  • Device operating status label/tag, single-use

Batrik Green Padlock with Indicator - 00690521005198

Padlock Security Tags with indicator
Batrik Medical Manufacturing Inc
15-713-IND
In Commercial Distribution

  • 00690521005198 ()
15-713-IND

  • Device operating status label/tag, single-use

Rolling Stand with adapter A - 06936415904081

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
045-003428-00
In Commercial Distribution

  • 06936415904081 ()


  • General-purpose multi-parameter bedside monitor

SleepmateOral/Nasal Cannula with filter - 05707480041848

Oral/Nasal w/filter (50)
Ambu A/S
814320-000/50
In Commercial Distribution

  • 05707480041848 ()
  • 05707480133918 ()
814320-000/50

  • Polysomnograph

Surface Electrode, 4-pack with Interconnect - 00852184003458

No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003458 ()


  • Percutaneous electrical stimulation lead external pulse generator cable, reusable

PowerLook PRO with Tomo Detection - 00858012005878

The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution

  • 00858012005878 ()
DSC014-03-US

  • Basic diagnostic x-ray system application software
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