SEARCH RESULTS FOR: !ㅡ최신재테크디비구입금액%*텔레howDB(3808124 results)

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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-8033108-100
In Commercial Distribution

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


  • Insulin syringe/needle, basic
Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-32G
In Commercial Distribution

  • 10850011833732 ()
  • 00850011833735 ()
  • 80850011833731 ()


  • Blood lancet, single-use
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
NPN-32-04
In Commercial Distribution

  • 10850011833695 ()
  • 00850011833698 ()
  • 80850011833694 ()


  • Autoinjector needle
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
NPN-31-08
In Commercial Distribution

  • 80850011833687 ()
  • 00850011833681 ()


  • Autoinjector needle
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
NPN-31-06
In Commercial Distribution

  • 10850011833671 ()
  • 00850011833674 ()
  • 80850011833670 ()


  • Autoinjector needle
GYN LAPAROSCOPY
MEDLINE INDUSTRIES, INC.
DYNJ900357L
In Commercial Distribution

  • 10193489669930 ()
DYNJ900357L

  • General surgical procedure kit, non-medicated, single-use
EAR CDS
MEDLINE INDUSTRIES, INC.
DYNJ900356L
In Commercial Distribution

  • 10193489669923 ()
DYNJ900356L

  • General surgical procedure kit, non-medicated, single-use
AIRWAY PACK
MEDLINE INDUSTRIES, INC.
DYNJ57770A
In Commercial Distribution

  • 10193489669916 ()
  • 40193489669917 ()
DYNJ57770A

  • General surgical procedure kit, non-medicated, single-use
ORTHOPEDIC PACK LARGE
MEDLINE INDUSTRIES, INC.
DYNJ62589
In Commercial Distribution

  • 10193489669909 ()
  • 40193489669900 ()
DYNJ62589

  • General surgical procedure kit, non-medicated, single-use
RADIAL CATH PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ37330F
In Commercial Distribution

  • 10193489669893 ()
  • 40193489669894 ()
DYNJ37330F

  • General surgical procedure kit, non-medicated, single-use
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