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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Advocate Lancing Device Red Dot, ergonomically designed, safety switch feature locks the trigger when uncapped, 6 depth adjustment, safer, easier lancet ejection
DIABETIC SUPPLY OF SUNCOAST, INC.
329
In Commercial Distribution

  • 00852982006002 ()
  • 10852982006009 ()
  • 20852982006006 ()
329

  • Manual blood lancing device, reusable
Oral Irrigator
PANASONIC CORPORATION OF NORTH AMERICA
EW-DJ66-W351
In Commercial Distribution

  • 00851439007128 ()


  • Water jet flosser/sonic electric toothbrush
No Description
PANASONIC CORPORATION OF NORTH AMERICA
ER-CTB1-A
In Commercial Distribution

  • 00851439007098 ()
  • 10851439007095 ()


  • Water jet flosser/sonic electric toothbrush
Large Cuff for Panasonic Arm Blood Pressure Monitor
PANASONIC CORPORATION OF NORTH AMERICA
EW3901
In Commercial Distribution

  • 10851439007088 ()
  • 00851439007081 ()


  • Blood pressure cuff, reusable
Oral Irrigator
PANASONIC CORPORATION OF NORTH AMERICA
EW-DJ11-A551
In Commercial Distribution

  • 00851439007074 ()


  • Water jet flosser/sonic electric toothbrush
No Description
PANASONIC CORPORATION OF NORTH AMERICA
EW-DJ10-W551
In Commercial Distribution

  • 00851439007050 ()
  • 10851439007057 ()


  • Water jet flosser/sonic electric toothbrush
No Description
PANASONIC CORPORATION OF NORTH AMERICA
EW1213A351
In Commercial Distribution

  • 00851439007043 ()
  • 10851439007040 ()


  • Water jet flosser/sonic electric toothbrush
No Description
PANASONIC CORPORATION OF NORTH AMERICA
EW1511W551
In Commercial Distribution

  • 00851439007036 ()
  • 10851439007033 ()


  • Water jet flosser/sonic electric toothbrush
No Description
PANASONIC CORPORATION OF NORTH AMERICA
EW1611W551
In Commercial Distribution

  • 00851439007012 ()
  • 10851439007019 ()


  • Water jet flosser/sonic electric toothbrush
2x4" rectangle white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.
ELITE MEDICAL SUPPLY OF NY
SF50100WP
In Commercial Distribution

  • 00860019001654 ()

  • Length: 4 Inch
  • Width: 2 Inch


  • Interferential electrical stimulation system electrode
The Elite Medical Supply of NY PMD2000 Multi-Mode Stimulator (MMS) (the Device) is a battery and 110V wall adapter powered electrotherapy devices intended for clinic and outpatient rehabilitative therapy, acute postoperative care and home use for patients suffering from a variety of chronic pain issues. Prescribed by a physician, it gives the clinician a variety of electrotherapy modes to treat a range of indications. The Device is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The Intended Use Environment is Home Healthcare but the Device can also be used in a Chiropractic, Physical Therapy or Pain Management Clinic. The Device uses a tactile button user interface for control of the operating system and therapy amplitude settings. The Device has a liquid crystal character display which provides information to the user and displays the current therapy settings. The Device’s therapeutic output is transmitted through the patient lead wires to the cutaneous hydrogel electrodes affixed to the user’s skin. The energy generated by the Device is conveyed, via the patient lead wires and cutaneous electrodes, through the patients skin to excite either the underlying motor nerves to elicit involuntary muscle contractions or the sensory nerves to manage pain.
ELITE MEDICAL SUPPLY OF NY
PMD2000
In Commercial Distribution

  • 00860019001647 ()
  • 00860019001630 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Interferential electrical stimulation system
2" square white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.
ELITE MEDICAL SUPPLY OF NY
SF5050WP
In Commercial Distribution

  • 00860019001616 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • Interferential electrical stimulation system electrode
The Elite Medical Supply of NY EMS100 Tri-Wave Combination Stimulator (the Device) is a battery and 110V wall adapter powered electrotherapy devices intended for clinic and outpatient rehabilitative therapy, acute postoperative care and home use for patients suffering from a variety of chronic pain issues. Prescribed by a physician, it gives the clinician a variety of electrotherapy modes to treat a range of indications. The Device is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The Intended Use Environment is Home Healthcare but the Device can also be used in a Chiropractic, Physical Therapy or Pain Management Clinic. The Device uses a tactile button user interface for control of the operating system and therapy amplitude settings. The Device has a liquid crystal character display which provides information to the user and displays the current therapy settings. The Device’s therapeutic output is transmitted through the patient lead wires to the cutaneous hydrogel electrodes affixed to the user’s skin. The energy generated by the Device is conveyed, via the patient lead wires and cutaneous electrodes, through the patients skin to excite either the underlying motor nerves to elicit involuntary muscle contractions or the sensory nerves to manage pain.
ELITE MEDICAL SUPPLY OF NY
EMS100
Not in Commercial Distribution

  • 00860019001623 ()
  • 00860019001609 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Interferential electrical stimulation system
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
ASSOCIATES OF CAPE COD, INC.
0
In Commercial Distribution

  • 00862696000289 ()


  • Laboratory instrument/analyser application software IVD
No Description
ASSOCIATES OF CAPE COD, INC.
1
In Commercial Distribution

  • 00862696000227 ()


  • 1,3-Beta-D-glucan IVD, kit, spectrophotometry
Reconditioned and recycled FaceMaster Platinum Facial Toning System
FACEMASTER OF BEVERLY HILLS, INC.
Platinum
In Commercial Distribution

  • 00879314000033 ()
700016-A

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
FaceMaster Platinum Facial Toning System
FACEMASTER OF BEVERLY HILLS, INC.
Platinum
In Commercial Distribution

  • 00879314000026 ()
700015-A

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
W.O.M. World of Medicine GmbH
PS304
In Commercial Distribution

  • 04056702012878 ()


  • Hysteroscopic irrigation/insufflation system
No Description
W.O.M. World of Medicine GmbH
PH304
In Commercial Distribution

  • 04056702012861 ()


  • Hysteroscopic irrigation/insufflation system
No Description
W.O.M. World of Medicine GmbH
INSFSWITCH
In Commercial Distribution

  • 04056702010980 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFCDISS3
In Commercial Distribution

  • 04056702010973 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFCHSEAGA
In Commercial Distribution

  • 04056702010966 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFCHSEUNI
In Commercial Distribution

  • 04056702010959 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFCHSENF
In Commercial Distribution

  • 04056702010942 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFCHSEDIN
In Commercial Distribution

  • 04056702010935 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFDISSADP
In Commercial Distribution

  • 04056702010928 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFUNI
In Commercial Distribution

  • 04056702010911 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFUNIANGL
In Commercial Distribution

  • 04056702010904 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFBHSEPIN
In Commercial Distribution

  • 04056702010898 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFBHSEISO
In Commercial Distribution

  • 04056702010881 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INSFBHSEDIN
In Commercial Distribution

  • 04056702010874 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
ZEOSINSUFF
In Commercial Distribution

  • 04056702008895 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
INTUBWVACC
In Commercial Distribution

  • 04056702008888 ()
  • 04056702008871 ()


  • Disposable vacuum tubing
No Description
W.O.M. World of Medicine GmbH
INFLWTBING
In Commercial Distribution

  • 04056702008864 ()
  • 04056702008857 ()


  • Surgical irrigation tubing set, single-use
No Description
W.O.M. World of Medicine GmbH
OTFLWTBING2
In Commercial Distribution

  • 04056702008826 ()
  • 04056702008819 ()


  • Disposable vacuum tubing
No Description
W.O.M. World of Medicine GmbH
GAMMA FINDER® III
In Commercial Distribution

  • 04056702007973 ()


  • Hand-held-detector nuclear medicine system
No Description
W.O.M. World of Medicine GmbH
Z5044-01
In Commercial Distribution

  • 04056702007348 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
Z5045-01
In Commercial Distribution

  • 04056702007331 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
Z5101-01
In Commercial Distribution

  • 04056702007324 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
Z5130-01
In Commercial Distribution

  • 04056702007317 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
Z5105-01
In Commercial Distribution

  • 04056702007300 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
Z5107-01
In Commercial Distribution

  • 04056702007294 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
Z5108-01
In Commercial Distribution

  • 04056702007287 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
Z5075-01
In Commercial Distribution

  • 04056702007249 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
Z0499-01
In Commercial Distribution

  • 04056702007225 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
FM134
In Commercial Distribution

  • 04056702007218 ()


  • Laparoscopic insufflator
No Description
W.O.M. World of Medicine GmbH
AQL-100PBS
In Commercial Distribution

  • 04056702006914 ()


  • Hysteroscopic irrigation/insufflation system
No Description
W.O.M. World of Medicine GmbH
GAMMA FINDER® III
In Commercial Distribution

  • 04056702006600 ()


  • Hand-held-detector nuclear medicine system
No Description
W.O.M. World of Medicine GmbH
AQL-100CBS
In Commercial Distribution

  • 04056702006556 ()


  • Hysteroscopic irrigation/insufflation system
No Description
W.O.M. World of Medicine GmbH
PS304
In Commercial Distribution

  • 04056702006273 ()


  • Hysteroscopic irrigation/insufflation system
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