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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 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
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-8033108-100
In Commercial Distribution

  • 10850011833756 ()
  • 00850011833759 ()
  • 80850011833755 ()


  • Insulin syringe/needle, basic
Bio-Reign 3D Block 14mm x 10mm x 14mm
ROYAL BIOLOGICS INC.
BR-b14x10x14
In Commercial Distribution

  • 00850014593773 ()
BR-b14x10x14

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 125mm x 5mm
ROYAL BIOLOGICS INC.
BR-s25x125x5
In Commercial Distribution

  • 00850014593766 ()
BR-s25x125x5

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 75mm x 5mm
ROYAL BIOLOGICS INC.
BR-s25x75x5
In Commercial Distribution

  • 00850014593759 ()
BR-s25x75x5

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 50mm x 5mm
ROYAL BIOLOGICS INC.
BR-s25x50x5
In Commercial Distribution

  • 00850014593742 ()
BR-s25x50x5

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 25mm x 5mm
ROYAL BIOLOGICS INC.
BR-s25x25x5
In Commercial Distribution

  • 00850014593735 ()
BR-s25x25x5

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 125mm x 3mm
ROYAL BIOLOGICS INC.
BR-s25x125x3
In Commercial Distribution

  • 00850014593728 ()
BR-s25x125x3

  • Synthetic bone graft
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