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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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Sterile Latex Powder-Free Surgical gloves - Brown
Motex Healthcare(Anhui)Co.,Ltd.
2829F/9
In Commercial Distribution

  • 36971384153321 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Latex Powder-Free Surgical gloves - Brown
Motex Healthcare(Anhui)Co.,Ltd.
2821S/9
In Commercial Distribution

  • 36971384153222 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Latex Powder-Free Surgical gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
2729S/9
In Commercial Distribution

  • 36971384153123 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Latex Powder-Free Surgical gloves
Motex Healthcare(Anhui)Co.,Ltd.
2729F/9
In Commercial Distribution

  • 36971384153024 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Latex Powder-Free Surgical gloves
Motex Healthcare(Anhui)Co.,Ltd.
2721S/9
In Commercial Distribution

  • 36971384152928 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Latex Powder-Free Surgical gloves
Motex Healthcare(Anhui)Co.,Ltd.
2721F/9
In Commercial Distribution

  • 36971384152829 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
No Description
APK Technology Co.,Ltd.
A-XT-08D(9)
In Commercial Distribution

  • 06946725526934 ()


  • Blood pressure cuff, single-use
No Description
APK Technology Co.,Ltd.
A-XT-08W(9)
In Commercial Distribution

  • 06946725526804 ()


  • Blood pressure cuff, reusable
No Description
APK Technology Co.,Ltd.
A-XT-03D(9)
In Commercial Distribution

  • 06946725523537 ()


  • Blood pressure cuff, single-use
No Description
APK Technology Co.,Ltd.
A-XT-02W(9)
In Commercial Distribution

  • 06946725523414 ()


  • Blood pressure cuff, reusable
No Description
CHISON Medical Technologies Co., Ltd.
CBit 9
In Commercial Distribution

  • 06945121413039 ()
  • 06945121413015 ()
  • 06945121413053 ()
  • 06945121413404 ()
  • 06945121413411 ()
  • 06945121414623 ()
  • 06945121414630 ()
  • 06945121414692 ()
  • 06945121414647 ()
  • 06945121414654 ()
  • 06945121414661 ()
  • 06945121414678 ()
  • 06945121414685 ()


  • General-purpose ultrasound imaging system
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
9.x
Not in Commercial Distribution

  • 00884838075894 ()


  • Radiology DICOM image processing application software
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Style 9
In Commercial Distribution

  • M724N9NS1 ()
N 9-NS

  • Nasal cartilage support implant, non-bioabsorbable
2010-056 Laryngectomy Pulmonary Kit 9/36 With Provox® Standard LaryTube™ and SolaTone® Electrolarynx
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020603 ()
2010-056

  • Transcervical artificial larynx
  • Airway device cleaning utensil, noninvasive, reusable
  • Tracheostoma shower shield
  • Tracheostomy tube neck holder, reusable
  • Tracheostomy tube, non-reinforced, non-customized, reusable
  • Tracheostoma protective filter
Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and Liberty™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020528 ()
2010C-07E6

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/55 With Provox® LaryTube™ with Ring and Provox® OptiDerm™ Adhesive
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020511 ()
2010-27

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit With Standard Provox® LaryTube™ 9/27
ATOS MEDICAL INC.
9/27
Not in Commercial Distribution

  • 00817126020436 ()
2010-05

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and Servox™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020412 ()
2010-07E4

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and TruTone™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020375 ()
2010-07E1

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/36 With Provox® Standard LaryTube™ and TruTone™ Electrolarynx
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020368 ()
2010-06E1

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020344 ()
2010C3-02

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and Liberty™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020306 ()
2010C4-07E6

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/36 With Provox® Standard LaryTube™ and Liberty™ Electrolarynx
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020269 ()
2010-06E6

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and LaryClips™
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020245 ()
2010-02LC

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/36 With Provox® Fenestrated LaryTube™
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020191 ()
2010-401

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit With Standard Provox® LaryTube™ 9/36
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020160 ()
2010-01

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/36 With Provox® Fenestrated LaryTube™
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020146 ()
2010-40

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/55 With Provox® Fenestrated LaryTube™
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020139 ()
2010-41

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and Liberty™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020122 ()
2010-07E6

  • Tracheoesophageal speech valve, indwelling
Laryngectomy Pulmonary Kit 9/55 W/ Provox Vega 17Fr 8mm, Guide Wire, and Provox Vega Plug
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020115 ()
2012-07

  • Tracheoesophageal speech valve, indwelling
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