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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20-23 Black Spectacle
Kenmark Optical, Inc.
2023BK53
In Commercial Distribution

  • 00715317081238 ()


  • Prescription spectacles
20-23 Grey Spectacle
Kenmark Optical, Inc.
2023GR53
In Commercial Distribution

  • 00715317081153 ()


  • Prescription spectacles
20-23 Sky Spectacle
Kenmark Optical, Inc.
2023SK53
In Commercial Distribution

  • 00715317081146 ()


  • Prescription spectacles
Probe-Explorer, 20-23, Double-Ended, Tactile Tone™
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
EE2023
Not in Commercial Distribution

  • H834EE20230 ()
  • 10381780235071 ()
EE2023

  • Periodontal probe, reusable
Revised version of TR-ZX2 from 2023.
J.MORITA MFG.CORP.
TR-ZX2 Type PLUS
In Commercial Distribution

  • 04548213055999 ()


  • Dental surgical power tool motorized handpiece/set, electric
  • Endodontic apex locator
BANDAGE WOVEN FINGERTIP
Prostat First Aid, LLC
2023
In Commercial Distribution

  • 00814889011206 ()


  • Adhesive bandage
Irrigation & Aspiration
HURRICANE MEDICAL INC
2023
In Commercial Distribution

  • 00813465010169 ()
  • 10813465010166 ()

  • Length: 22 Millimeter
  • Needle Gauge: 23 Gauge
2023

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Micro-OSMETTE Sample Tubes, 50 ul, 500/pk
Precision Systems, Inc.
2023
In Commercial Distribution

  • 00850041049236 ()
2023

  • General laboratory container, single-use
No Description
ARROW MEDSOURCE GROUP LIMITED
2023
Not in Commercial Distribution

  • 00850017650237 ()
  • 00850017650244 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
ARROW MEDSOURCE GROUP LIMITED
2023
In Commercial Distribution

  • 10850017650234 ()
  • 00850017650237 ()
  • 00850017650398 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
DIO Corporation
PP 2023
In Commercial Distribution

  • 08800049202197 ()


  • Dental guided surgery reference pin
SINGLE SUNGLASS
Evolutioneyes, Inc.
NM SUN 2023
In Commercial Distribution

  • 00802807353927 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
MS SUN 2023
In Commercial Distribution

  • 00802807353903 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
ME SUN 2023
In Commercial Distribution

  • 00802807353910 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
748 50 2023
In Commercial Distribution

  • 04571445051514 ()


  • Spectacle frame
No Description
EYEVAN INC.
554 47 2023
In Commercial Distribution

  • 04571445049689 ()


  • Spectacle frame
No Description
EYEVAN INC.
414 46 2023
In Commercial Distribution

  • 04571445048651 ()


  • Spectacle frame
No Description
EYEVAN INC.
#414 46 2023
In Commercial Distribution

  • 04571445035347 ()


  • Spectacle frame
SINGLE READER
Evolutioneyes, Inc.
4221 2023 DEMI MERLOT
In Commercial Distribution

  • 00802807355129 ()


  • Magnifying spectacles
Advanced Waterproof, Fast Healing Hydrocolloid Gel Pad Bandages, all one size, 2 IN x 3 IN
HARMON STORES, INC.
017276235340
Not in Commercial Distribution

  • 10017276235347 ()
  • 00017276235340 ()
  • 60017276235342 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Antibacterial Flexible Fabric Sterile Bandages, all one size 3/4 IN x 3 IN (19 mm x 76 mm)
RITE AID CORPORATION
011822472371
Not in Commercial Distribution

  • 10011822472378 ()
  • 00011822472371 ()
  • 60011822472373 ()


  • Skin-cover adhesive strip, antimicrobial
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-1H2-12X20
Not in Commercial Distribution

  • 00081215031744 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-4021-10NKP
Not in Commercial Distribution

  • 00893398002998 ()


  • External nasal splint
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-3000-10NKS
Not in Commercial Distribution

  • 00893398002981 ()


  • External nasal splint
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-3000-10NKP
Not in Commercial Distribution

  • 00893398002974 ()


  • External nasal splint
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-3000-10NKM
Not in Commercial Distribution

  • 00893398002967 ()


  • External nasal splint
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-3000-10NKL
Not in Commercial Distribution

  • 00893398002950 ()


  • External nasal splint
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-2000-10NKS
Not in Commercial Distribution

  • 00893398002943 ()


  • External nasal splint
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-2000-10NKP
Not in Commercial Distribution

  • 00893398002936 ()


  • External nasal splint
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
10-2000-10NKM
Not in Commercial Distribution

  • 00893398002929 ()


  • External nasal splint
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