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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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Tinto BG8 LewisY - B502BSB63750

BG8 LewisY is an antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB63750 ()
BSB 6375

  • Lewis y antigen IVD, antibody

Tinto BG8 LewisY - B502BSB63740

BG8 LewisY is an antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB63740 ()
BSB 6374

  • Lewis y antigen IVD, antibody

Tinto BG8 LewisY - B502BSB63730

BG8 LewisY is an antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB63730 ()
BSB 6373

  • Lewis y antigen IVD, antibody

Eagle - 07290018686027

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

Verifine - 00850011833834

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

Verifine - 00850011833827

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

Verifine - 00850011833797

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

Verifine - 00850011833780

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

Verifine - 00850011833773

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

Verifine - 00850011833766

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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