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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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MocareHealth - 36971384153321

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

MocareHealth - 36971384153222

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

MocareHealth - 36971384153123

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

MocareHealth - 36971384153024

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

MocareHealth - 36971384152928

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

MocareHealth - 36971384152829

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

Blood pressure cuff - 06946725526934

No Description
APK Technology Co.,Ltd.
A-XT-08D(9)
In Commercial Distribution

  • 06946725526934 ()


  • Blood pressure cuff, single-use

Blood pressure cuff - 06946725526804

No Description
APK Technology Co.,Ltd.
A-XT-08W(9)
In Commercial Distribution

  • 06946725526804 ()


  • Blood pressure cuff, reusable

Blood pressure cuff - 06946725523537

No Description
APK Technology Co.,Ltd.
A-XT-03D(9)
In Commercial Distribution

  • 06946725523537 ()


  • Blood pressure cuff, single-use

Blood pressure cuff - 06946725523414

No Description
APK Technology Co.,Ltd.
A-XT-02W(9)
In Commercial Distribution

  • 06946725523414 ()


  • Blood pressure cuff, reusable

CBit Series Digital Color Doppler Ultrasound System - 06945121413015

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 - 00884838075894

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 - M724N9NS1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Style 9
In Commercial Distribution

  • M724N9NS1 ()
N 9-NS

  • Nasal cartilage support implant, non-bioabsorbable

Atos Medical - 00817126020603

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

Atos Medical - 00817126020528

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

Atos Medical - 00817126020511

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

Atos Medical - 00817126020436

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

Atos Medical - 00817126020412

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

Atos Medical - 00817126020375

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

Atos Medical - 00817126020368

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

Atos Medical - 00817126020344

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

Atos Medical - 00817126020306

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

Atos Medical - 00817126020269

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

Atos Medical - 00817126020245

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

Atos Medical - 00817126020191

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

Atos Medical - 00817126020160

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

Atos Medical - 00817126020146

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

Atos Medical - 00817126020139

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

Atos Medical - 00817126020122

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

Atos Medical - 00817126020115

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

Atos Medical - 00817126020108

Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020108 ()
2010-02

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020078

Laryngectomy Pulmonary Kit 9/55 - Fenestrated Provox Vega Puncture Set 20Fr 10mm
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020078 ()
2045-41

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020054

Laryngectomy Pulmonary Kit 9/55 W/ Provox Vega 20Fr 10mm, Guide Wire, and Provox Vega Plug
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020054 ()
2023-07

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020047

Laryngectomy Pulmonary Kit 9/36 W/ Provox 2, Guide Wire, and Provox 2 Plug
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020047 ()
2019-06P1

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020030

Laryngectomy Pulmonary Kit 9/55 Provox Vega Puncture Set 20Fr 10mm
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020030 ()
2045-07

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020023

Laryngectomy Pulmonary Kit 9/36 W/ Provox 2, Guide Wire, and Provox 2 Plug
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020023 ()
2018-06P1

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020016

Laryngectomy Pulmonary Kit 9/55 - Fenestrated Provox Vega Puncture Set 17Fr 10mm
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020016 ()
2041-41

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020009

Laryngectomy Pulmonary Kit 9/55 W/ Provox 2, Guide Wire, and Provox 2 Plug
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020009 ()
2019-07P1

  • Tracheoesophageal speech valve, indwelling

Darby Dental Supply, LLC - 00889813012178

CARBIDE BUR EF 9 TF DARBY
DARBY DENTAL SUPPLY, LLC
9 TF
In Commercial Distribution

  • 00889813012178 ()
  • 00889813012161 ()
9525681

  • Carbide dental bur, reusable

SSG10 - 08809260474987

BSG10/FUS12/MBP20SX/TST20NN04
Saeshin Precision Co., Ltd.
SSG10 #9
In Commercial Distribution

  • 08809260474987 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

MyCRO Band - 04064409000104

MyCRO Band w/Lining beige
OTTO BOCK HEALTHCARE
24H1=9
In Commercial Distribution

  • 04064409000104 ()


  • Cranial orthosis

UTF™ Stem - 04719872167167

UTF Broach, #9
UNITED ORTHOPEDIC CORP.
9106-6009
In Commercial Distribution

  • 04719872167167 ()

  • #9
9106-6009

  • Orthopaedic broach

NOVAPLUS - 10014566700905

NOVAPLUS® GAMMEX® Non-Latex PI Textured Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
V20688290
In Commercial Distribution

  • 20014566700902 ()
  • 10014566700905 ()
  • 30014566700909 ()

  • 9
V20688290

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

NOVAPLUS - 10014566600908

NOVAPLUS® GAMMEX® Non-Latex PI Underglove Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
V20687290
In Commercial Distribution

  • 20014566600905 ()
  • 10014566600908 ()
  • 30014566600902 ()

  • 9
V20687290

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

NOVAPLUS - 10014566500901

NOVAPLUS® GAMMEX® Non-Latex PI Micro Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
V20685990
In Commercial Distribution

  • 20014566500908 ()
  • 10014566500901 ()
  • 30014566500905 ()

  • 9
V20685990

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

NOVAPLUS - 10014566400904

NOVAPLUS® GAMMEX® Non-Latex PI Green Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
V20685290
In Commercial Distribution

  • 20014566400901 ()
  • 10014566400904 ()
  • 30014566400908 ()

  • 9
V20685290

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

NOVAPLUS - 10014566300907

NOVAPLUS® GAMMEX® Non-Latex PI Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
V20685790
In Commercial Distribution

  • 20014566300904 ()
  • 10014566300907 ()
  • 30014566300901 ()

  • 9
V20685790

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

NOVAPLUS - 10014566201907

NOVAPLUS® ENCORE® Latex Ortho Size 9, Sterile Latex Powder-Free Surgical Glove
Ansell Healthcare Product
V5788007
In Commercial Distribution

  • 20014566201904 ()
  • 10014566201907 ()
  • 30014566201901 ()

  • 9
V5788007

  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

NOVAPLUS - 10014566200900

NOVAPLUS® GAMMEX® Non-Latex Size 9, Sterile Neoprene Powder-Free Surgical Glove
Ansell Healthcare Product
V8518
In Commercial Distribution

  • 20014566200907 ()
  • 10014566200900 ()
  • 30014566200904 ()

  • 9
V8518

  • Polychloroprene surgical glove, non-powdered

NOVAPLUS - 10014566100903

NOVAPLUS® GAMMEX® Non-Latex Sensitive Size 9, Sterile Neoprene Powder-Free Surgical Glove
Ansell Healthcare Product
V20277290
In Commercial Distribution

  • 20014566100900 ()
  • 10014566100903 ()
  • 30014566100907 ()

  • 9
V20277290

  • Polychloroprene surgical glove, non-powdered
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