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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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
Latex Powder Free Medical Gloves Size Small
GD CARE INC.
90005
In Commercial Distribution

  • B754900051 ()
  • B75490005 ()
  • B754900052 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Vinyl Powder Free Medical Gloves Size Extra Large
GD CARE INC.
70020
In Commercial Distribution

  • B754700201 ()
  • B75470020 ()
  • B754700202 ()


  • Vinyl examination/treatment glove, non-powdered
Vinyl Powder Free Medical Gloves Size Large
GD CARE INC.
70015
In Commercial Distribution

  • B754700151 ()
  • B75470015 ()
  • B754700152 ()


  • Vinyl examination/treatment glove, non-powdered
Nitrile Powder Free Examination Gloves Size Extra Large
GD CARE INC.
50020
In Commercial Distribution

  • B754500201 ()
  • B75450020 ()
  • B754500202 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Powder Free Examination Gloves Size Small
GD CARE INC.
50005
In Commercial Distribution

  • B754500051 ()
  • B75450005 ()
  • B754500052 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Powder Free Examination Size Extra Small
GD CARE INC.
50000
In Commercial Distribution

  • B754500001 ()
  • B75450000 ()
  • B754500002 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
33G x 5/32" (4mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335776
In Commercial Distribution

  • B7443357763 ()
  • B7443357762 ()
  • B7443357761 ()
  • B7443357760 ()


  • Autoinjector needle
32G X 5/32" (4mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335774
In Commercial Distribution

  • B7443357743 ()
  • B7443357742 ()
  • B7443357741 ()
  • B7443357740 ()


  • Autoinjector needle
31G X 5/16" (8mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335773
In Commercial Distribution

  • B7443357733 ()
  • B7443357732 ()
  • B7443357731 ()
  • B7443357730 ()


  • Autoinjector needle
31G X 3/16" (5mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335772
In Commercial Distribution

  • B7443357723 ()
  • B7443357722 ()
  • B7443357721 ()
  • B7443357720 ()


  • Autoinjector needle
29G X 1/2" (12mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335771
In Commercial Distribution

  • B7443357713 ()
  • B7443357712 ()
  • B7443357711 ()
  • B7443357710 ()


  • Autoinjector needle
1 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225941
In Commercial Distribution

  • B7442259413 ()
  • B7442259412 ()
  • B7442259411 ()
  • B7442259410 ()


  • Insulin syringe/needle, basic
0.5 ML 30GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225939
In Commercial Distribution

  • B7442259393 ()
  • B7442259392 ()
  • B7442259391 ()
  • B7442259390 ()


  • Insulin syringe/needle, basic
0.5 ML 30GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225938
In Commercial Distribution

  • B7442259383 ()
  • B7442259382 ()
  • B7442259381 ()
  • B7442259380 ()


  • Insulin syringe/needle, basic
0.5 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225937
In Commercial Distribution

  • B7442259373 ()
  • B7442259372 ()
  • B7442259371 ()
  • B7442259370 ()


  • Insulin syringe/needle, basic
0.3 ML 31GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225936
In Commercial Distribution

  • B7442259363 ()
  • B7442259362 ()
  • B7442259361 ()
  • B7442259360 ()


  • Insulin syringe/needle, basic
0.3 ML 30GX5/16" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225935
In Commercial Distribution

  • B7442259353 ()
  • B7442259352 ()
  • B7442259351 ()
  • B7442259350 ()


  • Insulin syringe/needle, basic
0.3 ML 30GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225934
In Commercial Distribution

  • B7442259343 ()
  • B7442259342 ()
  • B7442259341 ()
  • B7442259340 ()


  • Insulin syringe/needle, basic
0.3 ML 30GX1/2" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225933
In Commercial Distribution

  • B7442259333 ()
  • B7442259332 ()
  • B7442259331 ()
  • B7442259330 ()


  • Insulin syringe/needle, basic
0.3 ML 30GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225932
In Commercial Distribution

  • B7442259323 ()
  • B7442259322 ()
  • B7442259321 ()
  • B7442259320 ()


  • Insulin syringe/needle, basic
0.3 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225931
In Commercial Distribution

  • B7442259313 ()
  • B7442259312 ()
  • B7442259311 ()
  • B7442259310 ()


  • Insulin syringe/needle, basic
XCELL PC Fluid Volume Reducer 120ml XC-PSPC-120
APEX BIOLOGIX , LLC
XC-PSPC-120
In Commercial Distribution

  • B708XCPSPC1201 ()
  • B708XCPSPC1200 ()
  • B708XCPSPC1202 ()


  • Haematological concentrate system preparation kit, platelet concentration
DCTclock Test Form - Clinical
Linus Health, Inc.
10072
In Commercial Distribution

  • B626100722 ()
  • B626100721 ()
  • B626100720 ()
10072

  • Drawing-test cognitive function analysis device
DCTclock Test Form - Research
Linus Health, Inc.
10003
In Commercial Distribution

  • B626100030 ()
  • B626100031 ()
  • B626100032 ()
10003

  • Drawing-test cognitive function analysis device
The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The Lithotomy Drape also provides a sterile barrier between transurethral and rectal instruments, while also managing fluid collection. The Lithotomy Drape allows the physician to conduct an Aquablation® or other transurethral or transrectal urological procedures and reduce the risk of breaching sterility. The Lithotomy Drape, measuring 105 inches by 53 inches, is made of a Non-woven SMS textile, transparent poly sheeting, and a fluid pouch with a mesh screen.
PROCEPT BIOROBOTICS CORPORATION
351101
In Commercial Distribution

  • B6143511011 ()
  • B6143511018 ()
  • B6143511012 ()
351101

  • Patient surgical drape, single-use
No Description
GESIVA MEDICAL LLC
Medium High Tension Ring
In Commercial Distribution

  • B598GMMHT0001 ()
  • B598GMMHT0002 ()
  • B598GMTRK0001 ()


  • Penile vacuum device
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution

  • B595L2050R0 ()
  • B595L2050R1 ()
  • B595L2050R2 ()
L2050R

  • Pulse oximeter probe, reusable
  • Pulse Co-oximeter probe, reusable
No Description
DÜRR DENTAL SE
G3810
In Commercial Distribution

  • E247G38100 ()
  • E247G36201 ()
  • E247G36301 ()


  • Digital imaging storage phosphor screen
No Description
DÜRR DENTAL SE
RWT01.2A1
In Commercial Distribution

  • E24721301004160 ()
  • E247G37201 ()
  • E247G38201 ()


  • Dental x-ray film holder, reusable
No Description
DÜRR DENTAL SE
RWT01.3A1
In Commercial Distribution

  • E24721301004150 ()
  • E247G37301 ()
  • E247G38301 ()
2130100415

  • Dental x-ray film holder, reusable
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
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