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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The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
9" Camouflage
In Commercial Distribution

  • 00812594012433 ()
  • 10812594012430 ()
N9109CO

  • Tracheostomy tube neck holder, single-use
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
9" Blue
In Commercial Distribution

  • 00812594011351 ()
  • 10812594012362 ()
N9109BL

  • Tracheostomy tube neck holder, single-use
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
9" Tan
In Commercial Distribution

  • 00812594012297 ()
  • 10812594012294 ()
N9109TN

  • Tracheostomy tube neck holder, single-use
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
9" Pink
In Commercial Distribution

  • 00812594012228 ()
  • 10812594012225 ()
N9109PK

  • Tracheostomy tube neck holder, single-use
BSG10/FUS12/MBP20SX/TST20NN04
Saeshin Precision Co., Ltd.
SSG10 #9
In Commercial Distribution

  • 08809260474987 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
16:1, Contra Angle(Lever Type) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-42I
Saeshin Precision Co., Ltd.
X-CUBE #9
In Commercial Distribution

  • 08809260470866 ()


  • Dental power tool system, line-powered
NIC TONE Orthodontic Acrylic #9 190 g
MDC DENTAL
Orthodontic #9
In Commercial Distribution

  • 07506338319454 ()


  • Dental acrylic resin
NIC TONE Orthodontic Acrylic #9 90 g
MDC DENTAL
Orthodontic #9
In Commercial Distribution

  • 07506338319447 ()


  • Dental acrylic resin
NIC TONE Orthodontic Acrylic #9 35 g
MDC DENTAL
Orthodontic #9
In Commercial Distribution

  • 07506338319430 ()


  • Dental acrylic resin
NIC TONE QUARZ Rapid Acrylic #9 35 g
MDC DENTAL
Rapid #9
In Commercial Distribution

  • 07506338319003 ()


  • Dental acrylic resin
NIC TONE Orthodontic Acrylic #9 500 g
MDC DENTAL
Orthodontic #9
In Commercial Distribution

  • 07506338313193 ()


  • Dental acrylic resin
POZZI COBALT CLASP WIRE IN SPOOL .9MM
AMERICAN TOOTH INDUSTRIES
015-410/9
In Commercial Distribution

  • D77201541090 ()


  • Orthodontic wire
POZZI COBALT CLASP WIRE IN SPOOLS .9MM
AMERICAN TOOTH INDUSTRIES
015-400/9
In Commercial Distribution

  • D77201540090 ()


  • Orthodontic wire
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
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
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
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
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
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
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
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
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
IQ Dental Self Seal Sterilization Pouches 3.5X9 Box/200
IQ DENTAL SUPPLY LLC
NRG-SP35/9
In Commercial Distribution

  • 00816519020732 ()


  • Sterilization packaging, single-use
Sterile Polyisoprene Powder-Free Surgical Gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
7629S/9
In Commercial Distribution

  • 36971384154021 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Polyisoprene Powder-Free Surgical Gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
7621S/9
In Commercial Distribution

  • 36971384153925 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Polyisoprene Powder-Free Surgical Gloves - Blue
Motex Healthcare(Anhui)Co.,Ltd.
7529F/9
In Commercial Distribution

  • 36971384153826 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Polyisoprene Powder-Free Surgical Gloves - Blue
Motex Healthcare(Anhui)Co.,Ltd.
7521F/9
In Commercial Distribution

  • 36971384153727 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Nitrile Accelerator-Free and Sulfur-Free Powder-Free Surgical gloves - Green
Motex Healthcare(Anhui)Co.,Ltd.
7729F/9
In Commercial Distribution

  • 36971384153628 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Nitrile Accelerator-Free and Sulfur-Free Powder-Free Surgical gloves - Green
Motex Healthcare(Anhui)Co.,Ltd.
7721F/9
In Commercial Distribution

  • 36971384153529 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Sterile Latex Powder-Free Surgical gloves - Brown
Motex Healthcare(Anhui)Co.,Ltd.
2921S/9
In Commercial Distribution

  • 36971384153420 ()


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