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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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EZCare™ Softouch - 10812594012430

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

EZCare™ Softouch - 10812594012362

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

EZCare™ Softouch - 10812594012294

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

EZCare™ Softouch - 10812594012225

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

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

X-CUBE - 08809260470866

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, MDC Dental - 07506338319454

NIC TONE Orthodontic Acrylic #9 190 g
MDC DENTAL
Orthodontic #9
In Commercial Distribution

  • 07506338319454 ()


  • Dental acrylic resin

Nic Tone, MDC Dental - 07506338319447

NIC TONE Orthodontic Acrylic #9 90 g
MDC DENTAL
Orthodontic #9
In Commercial Distribution

  • 07506338319447 ()


  • Dental acrylic resin

Nic Tone, MDC Dental - 07506338319430

NIC TONE Orthodontic Acrylic #9 35 g
MDC DENTAL
Orthodontic #9
In Commercial Distribution

  • 07506338319430 ()


  • Dental acrylic resin

QUARZ, MDC Dental - 07506338319003

NIC TONE QUARZ Rapid Acrylic #9 35 g
MDC DENTAL
Rapid #9
In Commercial Distribution

  • 07506338319003 ()


  • Dental acrylic resin

Nic Tone, MDC Dental - 07506338313193

NIC TONE Orthodontic Acrylic #9 500 g
MDC DENTAL
Orthodontic #9
In Commercial Distribution

  • 07506338313193 ()


  • Dental acrylic resin

POZZI COBALT CLASP WIRE IN SPOOLS - D77201541090

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 - D77201540090

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

  • D77201540090 ()


  • Orthodontic wire

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

IQ Dental - 00816519020732

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

MocareHealth - 36971384154021

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
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