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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 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
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
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
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
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
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
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 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 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
Excel Fast is intended for use as a bracket adhesive. This is the Fast Set adhesive Part B in a 6gm syringe
RELIANCE ORTHODONTIC PRODUCTS INC
1EFSB
In Commercial Distribution

  • D7981EFSB0 ()
1EFSB

  • Orthodontic bracket adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023 B
In Commercial Distribution

  • D801SP65023B1 ()
65-023

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023
In Commercial Distribution

  • D801SP650231 ()
65-023

  • Dentine adhesive
The laser system is an ophthalmologic system based on femtosecond technology. It is used to treat a wide variety of ophthalmologic indications.
Technolas Perfect Vision GmbH
3.2
In Commercial Distribution

  • 04050555002895 ()
14000

  • Femtosecond ophthalmic solid-state laser system
A concentrated version of xMAP® Sheath Fluid, when diluted is is the delivery medium of the sample to the optics component.
LUMINEX CORPORATION
40-75680
In Commercial Distribution

  • 00840487100103 ()


  • Multiplex analyser IVD, laboratory
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product.
IMMUCOR, INC.
0066251
In Commercial Distribution

  • 10888234001300 ()
0066251

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Magenta
In Commercial Distribution

  • 04099702079632 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Green
In Commercial Distribution

  • 04099702079618 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Gray
In Commercial Distribution

  • 04099702079519 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Black
In Commercial Distribution

  • 04099702079496 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Starlight
In Commercial Distribution

  • 04099702079472 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
NEUROTUBE is designed for primary or secondary peripheral nerve repair or reconstruction. The NEUROTUBE device is resorbed through the process of hydrolysis.
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM0420NT
In Commercial Distribution

  • 00844735006193 ()

  • Length: 20 Millimeter
  • Lumen/Inner Diameter: 4.0 Millimeter
531101420011

  • Nerve guide, synthetic polymer, bioabsorbable
Model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
WELL-LIFE HEALTHCARE LTD.
WL-2407Rx
Not in Commercial Distribution

  • 04719872264088 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
This cuff is a sterile, single use product. This part number is a 44 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-107-00
In Commercial Distribution

  • M995607975107003 ()
  • M995607975107001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 34 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-106-00
In Commercial Distribution

  • M995607975106003 ()
  • M995607975106001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 30 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-105-00
In Commercial Distribution

  • M995607975105003 ()
  • M995607975105001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 24 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-104-00
In Commercial Distribution

  • M995607975104003 ()
  • M995607975104001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 18 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-103-00
In Commercial Distribution

  • M995607975103003 ()
  • M995607975103001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 44 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-107-00
In Commercial Distribution

  • M995607970107003 ()
  • M995607970107001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 34 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-106-00
In Commercial Distribution

  • M995607970106003 ()
  • M995607970106001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 30 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-105-00
In Commercial Distribution

  • M995607970105003 ()
  • M995607970105001 ()


  • Tourniquet cuff, single-use
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