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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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The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Single Upright Knee Orthosis (Left, Universal)
In Commercial Distribution

  • 00850012035244 ()
KO4351L

  • Knee support orthosis
The Unite Medical® Deluxe Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
Unite Medical, LLC
Deluxe Universal ROM Knee Brace
In Commercial Distribution

  • 00850012035138 ()
KO3233-1

  • Knee support orthosis
The Unite Medical® Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
Unite Medical, LLC
Universal ROM Knee Brace
In Commercial Distribution

  • 00850012035121 ()
KO3233

  • Knee support orthosis
The Sharps container is single-use, disposable, non-sterile containers intended to be used for health- care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.
Promisemed Medical Devices Inc.
SSC-005
In Commercial Distribution

  • 00850011833940 ()


  • Sharps container
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
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-8053108-100
In Commercial Distribution

  • 10850011833770 ()
  • 00850011833773 ()
  • 80850011833779 ()


  • 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-8052912-100
In Commercial Distribution

  • 10850011833763 ()
  • 00850011833766 ()
  • 80850011833762 ()


  • Insulin syringe/needle, basic
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