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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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Curaplex - 00815277021203

Curaplex Automated External Defibrillator (AED) Support Kit in Poly Bag
BOUND TREE MEDICAL, LLC
651776
In Commercial Distribution

  • 00815277021203 ()
  • 00810071639265 ()
651776

  • Dry medical towel/wipe, single-use
  • Cardiopulmonary resuscitation mask, single-use
  • Laboratory waste receptacle IVD
  • Antiseptic skin towelette
  • Safety razor, single-use
  • Bandage scissors, reusable
  • Nitrile examination/treatment glove, non-powdered, antimicrobial

AmCAD UO - 04719875623103

AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state.
AMCAD BIOMED CORPORATION
1.0
In Commercial Distribution

  • 04719875623103 ()
UO-0102

  • Ultrasound imaging system application software

MOPTIM - 06972039971023

The Handheld Auto Refractometer uses the infrared fundus reflection phase method to emit a beam of infrared light with a specific wavelength, through the subject's cornea, lens, etc., and finally projected to the eye retina, and then reflected back to the corresponding optical system of the instrument. The image is taken through the image sensor, and the spherical refraction power, cylindrical refraction power and astigmatism axis are calculated after image processing and signal processing, which is used to determine the refractive state of human eyes.
Shenzhen CERTAINN Technology Co., Ltd.
R3X
In Commercial Distribution

  • 06972039971023 ()


  • Automated ophthalmic refractometer

MOPTIM - 06972039971016

The Handheld Auto Refractometer uses the infrared fundus reflection phase method to emit a beam of infrared light with a specific wavelength, through the subject's cornea, lens, etc., and finally projected to the eye retina, and then reflected back to the corresponding optical system of the instrument. The image is taken through the image sensor, and the spherical refraction power, cylindrical refraction power and astigmatism axis are calculated after image processing and signal processing, which is used to determine the refractive state of human eyes.
Shenzhen CERTAINN Technology Co., Ltd.
R2X
In Commercial Distribution

  • 06972039971016 ()


  • Automated ophthalmic refractometer

Aura Wellness - 00850026680157

The Aura Wave Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits to the patient using magnetic fields. With an array of interchangeable coils, the system can be used to treat a variety of muscles. The Aura Wave is intended to maintain of encourage a general state of health by: - Massage like benefits to aid in personal relaxation - Like Massage, PEMF can provide relief from anxiety and stress - Provides joint and muscle relief due to strenuous sports and work activity - Benefits total wellness and life rejuvenation
Aura Wellness, LLC
Aura Wave Starter Kit
In Commercial Distribution

  • 00850026680157 ()
APN-00091

  • Deep-tissue electromagnetic stimulation system, home-use
  • Deep-tissue electromagnetic stimulation system, professional

Aura Wellness - 00850026680140

The Aura Wave Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits to the patient using magnetic fields. With an array of interchangeable coils, the system can be used to treat a variety of muscles. The Aura Wave is intended to maintain of encourage a general state of health by: - Massage like benefits to aid in personal relaxation - Like Massage, PEMF can provide relief from anxiety and stress - Provides joint and muscle relief due to strenuous sports and work activity - Benefits total wellness and life rejuvenation
Aura Wellness, LLC
Aura Wave
In Commercial Distribution

  • 00850026680140 ()
APN-00068

  • Deep-tissue electromagnetic stimulation system, home-use
  • Deep-tissue electromagnetic stimulation system, professional

Aura Wellness - 00850026680102

The Aura Pulse Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits to the patient using magnetic fields. With an array of interchangeable coils, the system can be used to treat a variety of muscles. The Aura Pulse is intended to maintain of encourage a general state of health by: - Massage like benefits to aid in personal relaxation - Like Massage, PEMF can provide relief from anxiety and stress - Provides joint and muscle relief due to strenuous sports and work activity - Benefits total wellness and life rejuvenation
Aura Wellness, LLC
Aura Pulse Starter Kit
In Commercial Distribution

  • 00850026680102 ()
APN-00050

  • Deep-tissue electromagnetic stimulation system, professional

Aura Wellness - 00850026680096

The Aura Pulse Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits to the patient using magnetic fields. With an array of interchangeable coils, the system can be used to treat a variety of muscles. The Aura Pulse is intended to maintain of encourage a general state of health by: - Massage like benefits to aid in personal relaxation - Like Massage, PEMF can provide relief from anxiety and stress - Provides joint and muscle relief due to strenuous sports and work activity - Benefits total wellness and life rejuvenation
Aura Wellness, LLC
Aura Pulse
In Commercial Distribution

  • 00850026680096 ()
APN-00062

  • Deep-tissue electromagnetic stimulation system, professional

MOPTIM - 06972039971214

The Handheld Auto Refractometer uses the infrared fundus reflection phase method to emit a beam of infrared light with a specific wavelength, through the subject's cornea, lens, etc., and finally projected to the eye retina, and then reflected back to the corresponding optical system of the instrument. The image is taken through the image sensor, and the spherical refraction power, cylindrical refraction power and astigmatism axis are calculated after image processing and signal processing, which is used to determine the refractive state of human eyes.
Shenzhen CERTAINN Technology Co., Ltd.
easyRef Pro
In Commercial Distribution

  • 06972039971214 ()


  • Automated ophthalmic refractometer

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (D2) - D77819930150

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: D2. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3015
In Commercial Distribution

  • D77819930150 ()

  • Weight: 4.5 Gram
199-3015

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (C2) - D77819930140

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: C2. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3014
In Commercial Distribution

  • D77819930140 ()

  • Weight: 4.5 Gram
199-3014

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (B4) - D77819930130

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: B4. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3013
In Commercial Distribution

  • D77819930130 ()

  • Weight: 4.5 Gram
199-3013

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (B1) - D77819930120

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: B1. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3012
In Commercial Distribution

  • D77819930120 ()

  • Weight: 4.5 Gram
199-3012

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (A4) - D77819930110

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A4. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3011
In Commercial Distribution

  • D77819930110 ()

  • Weight: 4.5 Gram
199-3011

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (OPAQ) - D77819930100

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: Opaque. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3010
In Commercial Distribution

  • D77819930100 ()

  • Weight: 4.5 Gram
199-3010

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (D4) - D77819930090

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: D4. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3009
In Commercial Distribution

  • D77819930090 ()

  • Weight: 4.5 Gram
199-3009

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (C3) - D77819930080

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: C3. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3008
In Commercial Distribution

  • D77819930080 ()

  • Weight: 4.5 Gram
199-3008

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (C1) - D77819930070

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: C1. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3007
In Commercial Distribution

  • D77819930070 ()

  • Weight: 4.5 Gram
199-3007

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (B3) - D77819930060

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: B3 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3006
In Commercial Distribution

  • D77819930060 ()

  • Weight: 4.5 Gram
199-3006

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (B2) - D77819930050

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: B2 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3005
In Commercial Distribution

  • D77819930050 ()

  • Weight: 4.5 Gram
199-3005

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (A3.5) - D77819930040

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A3.5 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3004
In Commercial Distribution

  • D77819930040 ()

  • Weight: 4.5 Gram
199-3004

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (A3) - D77819930030

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A3 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3003
In Commercial Distribution

  • D77819930030 ()

  • Weight: 4.5 Gram
199-3003

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (A2) - D77819930020

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A2 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3002
In Commercial Distribution

  • D77819930020 ()

  • Weight: 4.5 Gram
199-3002

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (A1) - D77819930010

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A1 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3001
In Commercial Distribution

  • D77819930010 ()

  • Weight: 4.5 Gram
199-3001

  • Dental composite resin

MES 9000 Dynamic EMG - D792N9200A0

The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its raw state or as integrated data. The powerful and user-friendly software simplifies the recording of multiple muscle groups of antagonist and synergist muscles to facilitate assessment and case documentation. In addition, the system includes pre-programmed protocols and analysis for assessment, muscle education and relaxation training. The clinician may also program custom protocols - quickly and simply.
MYOTRONICS NOROMED, INC
MES 9000 EMG
In Commercial Distribution

  • D792N9200A0 ()


  • Virtual-display rehabilitation system, non-supportive, clinical

PREMIER CAMPY - 00840733101717

Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.
MERIDIAN BIOSCIENCE, INC.
618096
In Commercial Distribution

  • 00840733101717 ()
618096

  • Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA)

ROTEM® - 04260160470587

The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System (US/CA)
In Commercial Distribution

  • 04260160470587 ()
201001

  • Coagulation analyser IVD, laboratory, semi-automated

ROTEM® - 04260160470020

The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System
In Commercial Distribution

  • 04260160470020 ()
200100-US

  • Coagulation analyser IVD, laboratory, semi-automated

PremierPro Lancet - 00811220030391

Description: Lancet, Push Button Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site and press the push-button to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
SVS LLC
7572
In Commercial Distribution

  • 10811220030398 ()
  • 00811220030391 ()

  • 23G x 1.8mm
7572

  • Blood lancing device tip

PremierPro Lancet - 00811220030377

Lancet, Pressure, 30G x 1.5mm, Green, 100/bx 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
SVS LLC
7553
In Commercial Distribution

  • 10811220030374 ()
  • 00811220030377 ()

  • 30G x 1.5mm
7553

  • Blood lancing device tip
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