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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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Medline Industries, Inc. - 10193489523652

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585
In Commercial Distribution

  • 10193489523652 ()
DYNJ60585

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

Supremo Instrumentos - 07908854000890

Broca Coletora com Capa 7.0
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S7923
In Commercial Distribution

  • 07908854000890 ()


  • Surgical screwdriver, reusable

NORDENT MANUFACTURING INC - 00840018636057

SPECIAL COM PLACM PER MICRODEN
NORDENT MANUFACTURING INC
PFICOMP14
In Commercial Distribution

  • 00840018636057 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635746

COM PLACEMENT INST DE WOODSN #
NORDENT MANUFACTURING INC
CEPFIW1
In Commercial Distribution

  • 00840018635746 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635548

COM PLACEMENT INST DE WOODSN #
NORDENT MANUFACTURING INC
REPFIW1
In Commercial Distribution

  • 00840018635548 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635401

COM PLACEM INSTDE, #37, DL-RND
NORDENT MANUFACTURING INC
REPFI37
In Commercial Distribution

  • 00840018635401 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634961

COM PLACEMENT INST DE - HOE
NORDENT MANUFACTURING INC
PFI4A-MT40
In Commercial Distribution

  • 00840018634961 ()


  • Margin finishing dental file/rasp, reusable

Easy III - 00840067100622

Easy III Power Com Module
CADWELL INDUSTRIES, INC.
190245-200
In Commercial Distribution

  • 00840067100622 ()


  • Electroencephalograph

Cascade Elite - 00840067100295

Cascade Elite Power/Com Module
CADWELL INDUSTRIES, INC.
190240-200
In Commercial Distribution

  • 00840067100295 ()


  • Neurophysiologic monitoring system

Medline Industries, Inc. - 10195327605544

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585C
In Commercial Distribution

  • 40195327605545 ()
  • 10195327605544 ()
DYNJ60585C

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

Medline Industries, Inc. - 10195327547776

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585B
In Commercial Distribution

  • 40195327547777 ()
  • 10195327547776 ()
DYNJ60585B

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

Brasseler USA - 00887919801467

K0354 MCLAREN UAB COM/BISACRYL
Peter Brasseler Holdings, LLC
5026493U0
In Commercial Distribution

  • 00887919801467 ()


  • Diamond dental bur, single-use

Vermed Holter Kit - 10813150021255

Packed for Cardio Options, Jacksonville, FL 32223 25 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
CARD98-3
In Commercial Distribution

  • 10813150021255 ()
  • 00813150021258 ()
CARD98-3

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150021248

Packed for Cardio Options, Jacksonville, FL 32223 25 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
CARD98-2
In Commercial Distribution

  • 10813150021248 ()
  • 00813150021241 ()
CARD98-2

  • Electrocardiographic long-term ambulatory recording support kit

NeXus-Q32 - 08719481550400

The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e.g. EEG, surface EMG or ECG) from humans, regardless of any specific medical indication, by medical/research professionals.
Mind Media Europe B.V.
3.0
In Commercial Distribution

  • 08719481550400 ()


  • Multiple physiological signal amplifier

NeXus-10 MKII - 08719481550349

The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications. The NeXus 10 MKII is intended for use on humans. The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software.
Mind Media Europe B.V.
1.2
In Commercial Distribution

  • 08719481550349 ()


  • Multiple physiological signal amplifier

NeXus Software - 08719481550332

The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution

  • 08719481550332 ()


  • Biofeedback system application software

GSR-TMP Combination Sensor (NC-C-GT) - 08719481550097

NC-C-GT: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes. The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550097 ()


  • General-purpose patient temperature probe, reusable
  • Skin electrical conductance meter

Temperature Sensor (NB-TMP) - 08719481550080

NB-TMP: The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550080 ()


  • General-purpose patient temperature probe, reusable

Galvanic Skin Response Sensor (NB-GSR) - 08719481550073

NB-GSR: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550073 ()


  • Skin electrical conductance meter
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