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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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Duotrodes are silver-silver chloride, bi-polar electrodes for surface EMG applications.
MYOTRONICS NOROMED, INC
6145
In Commercial Distribution

  • D79261453 ()
  • D79261451 ()
  • D79261452 ()


  • Analytical non-scalp cutaneous electrode
The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication.
MYOTRONICS NOROMED, INC
J5
In Commercial Distribution

  • D79244500 ()
  • D7924450C0 ()
  • D7924450J0 ()
4450

  • Analgesic transcutaneous electrical nerve stimulation system
36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total). A revolutionary electrode designed especially for use with the Myomonitor and BNS-40 unit.
MYOTRONICS NOROMED, INC
4300
In Commercial Distribution

  • D79243003 ()
  • D79243001 ()
  • D79243002 ()


  • Transcutaneous electrical stimulation electrode, single-use
Health-Tec EarLoop Masks, Sensitive, White
Dental Health Products Inc
450-10001
In Commercial Distribution

  • D773450100013 ()
  • D773450100011 ()
  • D773450100010 ()
  • D773450100015 ()
450-10001

  • Surgical/medical respirator, non-antimicrobial, single-use
The Renew® Finishing System is intended for use in the removal of composite paste after debonding and polishing of the surface of enamel, porcelain, metal or composite. The Renew Finishing System Points #383 will remove small residual amounts of adhesive from the tooth surface and will polish the enamel without damage. It's rubberized tapered shape facilitates removal of adhesive close to the gingiva. The #383 Point is the second step in the Renew Finishing System Points. This is the Friction Grip Finishing Point.
RELIANCE ORTHODONTIC PRODUCTS INC
*RSP
In Commercial Distribution

  • D798RSPFG0 ()
  • D798RSPFG3 ()
  • D798RSPFG2 ()
*RSP

  • Carbide dental bur, reusable
22 Gauge Tips for use with compatible syringes.
RELIANCE ORTHODONTIC PRODUCTS INC
22TIPS10
Not in Commercial Distribution

  • D79822TIPS102 ()
  • D79822TIPS101 ()
  • D79822TIPS100 ()
  • D79822TIPS103 ()
22TIPS10

  • Dental material injection cannula, single-use
A device with a handle used to plug the end of an anesthesia circuit/breathing circuit at two possible locations: the Y-piece or the gas sampling elbow. The temporary plugging of the anesthesia breathing circuit allows anesthetic gases to be flushed from the anesthesia machine through the WAG (waste anesthetic gas) scavenging line by way of continuous oxygen/air flow rate over a set amount of time, or by activating the flush valve and applying positive bag pressure in repeated succession. This practice reduces the amount of anesthetic gas released into the operating room and thus reduces harmful gas exposure to operating room personnel and premature anesthetic gas exposure to patients during preoxygenation or mask induction. There is no patient contact as the plug must be removed before the breathing circuit can be attached to a mask, endo/naso-tracheal tube, or any other breathing device.
INSTRUMENTATION INDUSTRIES, INCORPORATED
AM 100P
In Commercial Distribution

  • M996AM100P5 ()
  • M996AM100P0 ()
  • M996AM100P4 ()
AM 100P

  • Breathing circuit pressure detection port plug
Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff. 34" MLPS.
Delfi Medical Innovations Inc
9-7950-034
In Commercial Distribution

  • M995979500341 ()
  • M995979501343 ()
  • M995979500343 ()


  • Stockinette
No Description
DÜRR DENTAL SE
G3810
In Commercial Distribution

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


  • Digital imaging storage phosphor screen
A disposable universal dentist chair cover for the protection and safety of patients. Kit containing a headrest cover, a backrest cover and a seat cover made of non-woven polypropylene fabric. Made of 30 g/m2 non-woven fabric. Universal size. Carton of 25 single colour bags. Colour: blue
EURONDA SPA
KIT MONOART DENTIST CHAIR COVER
In Commercial Distribution

  • E3072640070 ()
  • E3072640072 ()
  • E3072640071 ()
264007

  • Medical equipment drape, single-use, non-sterile
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