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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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BiWaze Clear System - B965BK181

The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The BiWaze Clear System may be used with a patient interface like face mask, mouthpiece, a trach adapter to a patient’s endotracheal or tracheostomy tube. It is for use on adult or paediatric patients in acute, post-acute, and home care environments. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting
Abmrc LLC
BK181
In Commercial Distribution

  • B965BK367 ()
  • B965BK181 ()
  • B965BK368 ()
BK181

  • In-exsufflation/lung-oscillation airway secretion-clearing system

Health-Tec EarLoop Masks, Sensitive - D773450100011

Health-Tec EarLoop Masks, Sensitive, White
Dental Health Products Inc
450-10001
In Commercial Distribution

  • D773450100013 ()
  • D773450100011 ()
  • D773450100010 ()
  • D773450100015 ()
450-10001

  • Surgical/medical respirator, non-antimicrobial, single-use

Capture - D745701031CAP00300

Monophase Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0030
In Commercial Distribution

  • D745701031CAP00171 ()
  • D745701031CAP00300 ()
  • D745701028CAP00121 ()
70-1031-CAP0030

  • Silicone dental impression material

Capture - D745701031CAP00290

Monophase Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0029
In Commercial Distribution

  • D745701031CAP00181 ()
  • D745701031CAP00290 ()
  • D745701028CAP00091 ()
70-1031-CAP0029

  • Silicone dental impression material

Capture - D745701031CAP00280

Medium Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0028
In Commercial Distribution

  • D745701031CAP00131 ()
  • D745701031CAP00280 ()
  • D745701028CAP00111 ()
70-1031-CAP0028

  • Silicone dental impression material

Capture - D745701031CAP00270

Medium Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0027
In Commercial Distribution

  • D745701031CAP00141 ()
  • D745701031CAP00270 ()
  • D745701028CAP00101 ()
70-1031-CAP0027

  • Silicone dental impression material

Capture - D745701031CAP00260

Light Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0026
In Commercial Distribution

  • D745701031CAP00091 ()
  • D745701031CAP00260 ()
  • D745701028CAP00081 ()
70-1031-CAP0026

  • Silicone dental impression material

Capture - D745701031CAP00250

Light Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0025
In Commercial Distribution

  • D745701031CAP00101 ()
  • D745701031CAP00250 ()
  • D745701028CAP00061 ()
70-1031-CAP0025

  • Silicone dental impression material

Capture - D745701031CAP00240

Heavy Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0024
In Commercial Distribution

  • D745701031CAP00051 ()
  • D745701028CAP00041 ()
  • D745701031CAP00240 ()
70-1031-CAP0024

  • Silicone dental impression material

Capture - D745701031CAP00230

Heavy Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0023
In Commercial Distribution

  • D745701031CAP00061 ()
  • D745701028CAP00021 ()
  • D745701031CAP00230 ()
70-1031-CAP0023

  • Silicone dental impression material
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