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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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Black Nitrile Powder Free Examination Size Extra Small
GD CARE INC.
BLK50000
In Commercial Distribution

  • B754BLK500001 ()
  • B754BLK50000 ()
  • B754BLK500002 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Blue 3 ply Medical Face Mask
GD CARE INC.
BFM-001
In Commercial Distribution

  • B754BFM0011 ()
  • B754BFM001 ()
  • B754BFM0012 ()


  • Surgical/medical face mask, antimicrobial, single-use
Latex FIT Powder Free Medical Gloves Size Extra Large
GD CARE INC.
90020FIT
In Commercial Distribution

  • B75490020FIT1 ()
  • B75490020FIT0 ()
  • B75490020FIT2 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex Powder Free Medical Gloves Size Extra Large
GD CARE INC.
90020
In Commercial Distribution

  • B754900201 ()
  • B75490020 ()
  • B754900202 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex FIT Powder Free Medical Gloves Size Large
GD CARE INC.
90015FIT
In Commercial Distribution

  • B75490015FIT1 ()
  • B75490015FIT0 ()
  • B75490015FIT2 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex Powder Free Medical Gloves Size Large
GD CARE INC.
90015
In Commercial Distribution

  • B754900151 ()
  • B75490015 ()
  • B754900152 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex FIT Powder Free Medical Gloves Size Medium
GD CARE INC.
90010FIT
In Commercial Distribution

  • B75490010FIT1 ()
  • B75490010FIT0 ()
  • B75490010FIT2 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex Powder Free Medical Gloves Size Medium
GD CARE INC.
90010
In Commercial Distribution

  • B754900101 ()
  • B75490010 ()
  • B754900102 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Latex FIT Powder Free Medical Gloves Size Small
GD CARE INC.
90005FIT
In Commercial Distribution

  • B75490005FIT1 ()
  • B75490005FIT0 ()
  • B75490005FIT2 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Upper arm blood pressure monitor.
BODYTRACE, INC
BT104
In Commercial Distribution

  • B726BT1042 ()
  • B726BT1041 ()
  • B726BT1040 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Weight scale.
BODYTRACE, INC
BT005
In Commercial Distribution

  • B726BT005V1 ()
  • B726BT005V0 ()
  • B726BT005V2 ()


  • Stand-on floor scale, electronic
Weight scale.
BODYTRACE, INC
BT005
In Commercial Distribution

  • B726BT0051 ()
  • B726BT0050 ()
  • B726BT0052 ()


  • Stand-on floor scale, electronic
Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
Solo-Dex, Inc
70mm, Kit with filter
Not in Commercial Distribution

  • B3723000301015 ()
  • B372500001011 ()
  • B3721001385 ()

  • Length: 70 Millimeter
500001-01

  • Peripheral nerve-block sharp needle
The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance.
Corbin Clinical Resources, LLC
1
In Commercial Distribution

  • B371P10010 ()
  • B371P10012 ()
  • B371P10014 ()


  • Needle guide, single-use
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
Vitale Cover Dressings, 4" x 4", 30/box, 8 boxes/case
CELLERA LLC
24504
In Commercial Distribution

  • B492245042 ()
  • B492245041 ()
  • B492245040 ()
24504

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Cover Dressings, 2" x 2", 30/box, 8 boxes/case
CELLERA LLC
24502
In Commercial Distribution

  • B492245022 ()
  • B492245021 ()
  • B492245020 ()
24502

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Hydrogel Dressing, 4"x4", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
23844
In Commercial Distribution

  • B492238440 ()
  • B492238441 ()
  • B492238442 ()
23844

  • Wound hydrogel dressing, non-antimicrobial
Vitale Hydrogel Impregnated Dressing, 2x2, 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
23822
In Commercial Distribution

  • B492238222 ()
  • B492238221 ()
  • B492238220 ()
23822

  • Wound hydrogel dressing, non-antimicrobial
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