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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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PowerTENS - 06942808221093

PowerTENS is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
EasyMed Instruments Co., Ltd.
PowerTENS
In Commercial Distribution

  • 06942808221093 ()


  • Analgesic transcutaneous electrical nerve stimulation system

CurrentBody Skin™ - 00655729008235

The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MK66R-B
In Commercial Distribution

  • 00655729008235 ()


  • Cosmetic red-light phototherapy system, home-use

DropSafe Syringe with Safety Needle - 05903999600327

Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication.
HTL STREFA S A
1mL 25Gx1”
In Commercial Distribution

  • 05903999600327 ()
  • 15903999600324 ()
  • 25903999600321 ()
6073

  • General-purpose syringe/needle
  • Needle guard

DropSafe Syringe with Safety Needle - 05903999600310

Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication.
HTL STREFA S A
3mL 25Gx1”
In Commercial Distribution

  • 05903999600310 ()
  • 15903999600317 ()
  • 25903999600314 ()
6072

  • General-purpose syringe/needle
  • Needle guard

FaceLake - 00851908007062

The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturation (SpO2) and pulse rate through your finger.
LORTE TECHNOLOGIES, INC
CMS-50EW with Bluetooth
In Commercial Distribution

  • 00851908007062 ()


  • Pulse oximeter

NeoBridge® - 10812594010276

The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Large
In Commercial Distribution

  • 00812594010279 ()
  • 10812594010276 ()
N702

  • Wearable percutaneous catheter/tube holder

NeoBridge® - 10812594010269

The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Small
In Commercial Distribution

  • 00812594010262 ()
  • 10812594010269 ()
N701

  • Wearable percutaneous catheter/tube holder

NeoBridge® - 10812594010177

The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Mico
In Commercial Distribution

  • 00812594010170 ()
  • 10812594010177 ()
N700

  • Wearable percutaneous catheter/tube holder

Quick Cure - D798QCT0

Quick Cure is intended for use as a light cure bracket adhesive. This is a 5gm Push Syringe of Thin Viscosity Paste.
RELIANCE ORTHODONTIC PRODUCTS INC
QCT
Not in Commercial Distribution

  • D798QCT0 ()
QCT

  • Orthodontic bracket adhesive

BandLok - D798BLSA0

BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part A, natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSA
In Commercial Distribution

  • D798BLSA0 ()
BLSA

  • Orthodontic bracket adhesive
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