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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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Single use, medium respiratory belt.
Cleveland Medical Devices Inc.
Medium - Single
In Commercial Distribution

  • B143502020420 ()
  • B14360201311 ()
  • B14360201301 ()
502-0204-2

  • Electroencephalograph
Micro Applicators Fine (1.5mm) Mauve
Bright Supply, Inc.
BSI-1500
In Commercial Distribution

  • D974BSI15000 ()
  • D974BSI15001 ()
  • D974BSI15002 ()
  • D974BSI15003 ()


  • Dental material application tool, single-use
Micro Applicators Superfine (1.0mm) White
Bright Supply, Inc.
BSI-1000
In Commercial Distribution

  • D974BSI10002 ()
  • D974BSI10001 ()
  • D974BSI10003 ()
  • D974BSI10000 ()


  • Dental material application tool, single-use
Cotton Tipped applicator 6" small tip.
Bright Supply, Inc.
BSI-0006
In Commercial Distribution

  • D974BSI00062 ()
  • D974BSI00060 ()
  • D974BSI00061 ()
  • D974BSI00063 ()


  • General-purpose absorbent tip applicator/swab, single-use
Cotton Tipped applicator 3" small tip.
Bright Supply, Inc.
BSI-0003
In Commercial Distribution

  • D974BSI00032 ()
  • D974BSI00031 ()
  • D974BSI00030 ()
  • D974BSI00033 ()


  • General-purpose absorbent tip applicator/swab, single-use
Orthodontic appliance system, progressive FDA PT: HJDC
Digital Orthodontic Care
Aligners
In Commercial Distribution

  • D918SCA2 ()
  • D918SCA1 ()
  • D918SCA0 ()


  • Orthodontic progressive aligner
Gelling fiber wound dressing, 4"x4"
IMBED BIOSCIENCES, INC
91002
Not in Commercial Distribution

  • B519910022 ()
  • B519910021 ()
  • B519910020 ()

  • Area/Surface Area: 16 Square inch
91002

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Gelling fiber wound dressing, 2" x 2"
IMBED BIOSCIENCES, INC
91001
Not in Commercial Distribution

  • B519910012 ()
  • B519910011 ()
  • B519910010 ()

  • Area/Surface Area: 4 Square inch
91001

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of patient eye goggles ("ISEN-Goggles"). They have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USS port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for near-simultaneous viewing of the video images from both eyes on the attached LCD screen.
ISEN Tech. & Trading Co.,Ltd.
V06
In Commercial Distribution

  • B499V062 ()
  • B499V061 ()
  • B499V060 ()


  • Nystagmus inducing optokinetic drum
  • Nystagmus inducing tape
Vitale Cover Dressings, 6" x 6", 30/box, 10 boxes/case
CELLERA LLC
24506
In Commercial Distribution

  • B492245062 ()
  • B492245061 ()
  • B492245060 ()
24506

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
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