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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 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.
IPN-33-04
In Commercial Distribution

  • 10850011833275 ()
  • 00850011833278 ()
  • 80850011833274 ()


  • 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.
IPN-32-06
In Commercial Distribution

  • 10850011833268 ()
  • 00850011833261 ()
  • 80850011833267 ()


  • 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.
IPN-32-05
In Commercial Distribution

  • 10850011833251 ()
  • 00850011833254 ()
  • 80850011833250 ()


  • 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.
IPN-31-06
In Commercial Distribution

  • 10850011833244 ()
  • 00850011833247 ()
  • 80850011833243 ()


  • Autoinjector needle
Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Promisemed Medical Devices Inc.
SL-2124M
In Commercial Distribution

  • 10850011833237 ()
  • 00850011833230 ()
  • 80850011833236 ()


  • Blood lancet, single-use
Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Promisemed Medical Devices Inc.
SL-2118M
In Commercial Distribution

  • 10850011833206 ()
  • 00850011833209 ()
  • 80850011833205 ()


  • Blood lancet, single-use
Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Promisemed Medical Devices Inc.
SL-3018M
In Commercial Distribution

  • 10850011833138 ()
  • 00850011833131 ()
  • 80850011833137 ()


  • 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.
IPN-32-04
In Commercial Distribution

  • 10850011833046 ()
  • 00850011833049 ()
  • 80850011833045 ()


  • Autoinjector needle
No Description
RESOUNDANT, INC.
REFDAUX
In Commercial Distribution

  • 00850011790229 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software
No Description
RESOUNDANT, INC.
RESYS4001
In Commercial Distribution

  • 00850011790168 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESYS4001-RESYSAB
In Commercial Distribution

  • 00850011790151 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REPD2000
In Commercial Distribution

  • 00850011790106 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REFPDS19
In Commercial Distribution

  • 00850011790052 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REFPDL18
In Commercial Distribution

  • 00850011790045 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESY3002-RESYSAB
In Commercial Distribution

  • 00850011790021 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software
MedLite ID
Medlite ID
IDA01-CR
In Commercial Distribution

  • 00850011772010 ()
  • 00850011772003 ()


  • Intravenous line identification light
Wrench use to adjust helical screw on the ML7 Vacuum Rings
MED LOGICS INC
1350ML7
In Commercial Distribution

  • 00850011743997 ()
1350ML7

  • Microkeratome
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE30x40
In Commercial Distribution

  • 00850011613160 ()

  • 30mm x 40mm


  • Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE20x30
In Commercial Distribution

  • 00850011613153 ()

  • 20mm x 30mm


  • Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE15x20
In Commercial Distribution

  • 00850011613146 ()

  • 15mm x 20mm


  • Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD30x40
In Commercial Distribution

  • 00850011613054 ()

  • 30mm x 40mm


  • Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD20x30
In Commercial Distribution

  • 00850011613047 ()

  • 20mm x 30mm


  • Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD15x20
In Commercial Distribution

  • 00850011613030 ()

  • 15mm x 20mm


  • Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOF30x40
In Commercial Distribution

  • 00850011613023 ()

  • 30mm x 40mm


  • Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOF20x30
In Commercial Distribution

  • 00850011613016 ()

  • 20mm x 30mm


  • Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOF15x20
In Commercial Distribution

  • 00850011613009 ()

  • 15mm x 20mm


  • Collagen dental regeneration membrane
WaffleGrip Trendelenburg Positioning Kit for Electrosurgery, 10 Pack
AUGUSTINE TEMPERATURE MANAGEMENT LLC
A302
In Commercial Distribution

  • 00850011479711 ()
A302

  • Operating table non-slip back pad
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