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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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MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Gray
In Commercial Distribution

  • 04099702079519 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Black
In Commercial Distribution

  • 04099702079496 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Starlight
In Commercial Distribution

  • 04099702079472 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd: YAG laser that is intended for use in performing selective laser trabeculoplasty.
BELKIN VISION LTD
420840010
In Commercial Distribution

  • 07290018686027 ()


  • Ophthalmic solid-state laser system
This cuff is a sterile, single use product. This part number is a 44 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-107-00
In Commercial Distribution

  • M995607975107003 ()
  • M995607975107001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 34 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-106-00
In Commercial Distribution

  • M995607975106003 ()
  • M995607975106001 ()


  • Tourniquet cuff, single-use
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7103106-100
In Commercial Distribution

  • 10850011833831 ()
  • 00850011833834 ()
  • 80850011833830 ()


  • Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033106-100
In Commercial Distribution

  • 10850011833824 ()
  • 00850011833827 ()
  • 80850011833823 ()


  • Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8103108-100
In Commercial Distribution

  • 10850011833794 ()
  • 00850011833797 ()
  • 80850011833793 ()


  • Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8102912-100
In Commercial Distribution

  • 10850011833787 ()
  • 00850011833780 ()
  • 80850011833786 ()


  • Insulin syringe/needle, basic
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