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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Compact, lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Lite
In Commercial Distribution

  • B702P32C0 ()
P32C

  • Stand-on floor scale, electronic
  • Posturography system platform
  • Posturography system
The Nova HD Pulsed Electronic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, The Aura is easy to operate and incorporates many features to promote human health and well-being. The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body. The Nova HD is intended to be operated and used by the same person. The Nova HD produces non ionizing pulsed electromagnetic field at the applicator.
Aura Wellness, LLC
Nova HD Starter Kit
In Commercial Distribution

  • 00850026680065 ()
APN-00026

  • Deep-tissue electromagnetic stimulation system, home-use
The Nova HD Pulsed Electronic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, The Aura is easy to operate and incorporates many features to promote human health and well-being. The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body. The Nova HD is intended to be operated and used by the same person. The Nova HD produces non ionizing pulsed electromagnetic field at the applicator.
Aura Wellness, LLC
Nova HD
In Commercial Distribution

  • 00850026680003 ()
NOVA HD

  • Deep-tissue electromagnetic stimulation system, home-use
Lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). Its large surface allows for any stance. It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; mechanography; physical performance investigations; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Professional
In Commercial Distribution

  • B702P31C0 ()
P31C

  • Biomechanical function analysis/interactive rehabilitation system
  • Posturography system
  • Posturography system platform
  • Stand-on floor scale, electronic
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R138) Montana Jack™ (R223) 23 Explorer-12 Probe (R245) Cone Socket Mirror Handle (R269) 3-6 Discoid-Cleoid Carver (R284) Hollenback 1/2-3 Carver (R286) G2 Thin Composite (R287) G3 Thin Composite (R333) 27-29 Burnisher (R336) Calcium Hydroxide Placer (R347) 0-1 Blacks Plugger (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (R534) IPC-T Gold Line™ (Composite Sculpting System) (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T356) Amalgam Well (T800) Iris Curved Scissors (11.5cm)
PDT, INC.
R937 PDT Total Restorative Kit
In Commercial Distribution

  • 00813677024978 ()
R937

  • Instrument tray, reusable
  • Dental mirror, reusable
  • Dental irrigation/aspiration syringe
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental restoration carver, resin
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental restoration carver, amalgam, reusable
  • Manual dental burnisher, reusable
  • Dental amalgam condenser, reusable
  • Dental amalgam well
  • Gingival retraction cord packing tool
  • Dental spatula, reusable
  • Dental excavator, reusable
  • Suture scissors
The NATtrol™ Enterovirus (EV) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ EV Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Enterovirus Negative Control
In Commercial Distribution

  • 01220000260177 ()
NATEVNEG-6MC-IVD

  • Enterovirus nucleic acid (serotypes 68-71) IVD, control
The NATtrol™ Enterovirus (EV) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ EV Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Enterovirus Positive Control
In Commercial Distribution

  • 01220000260160 ()
NATEVPOS-6MC-IVD

  • Enterovirus nucleic acid (serotypes 68-71) IVD, control
The NATtrol™ Norovirus Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Norovirus Negative Control
In Commercial Distribution

  • 01220000260139 ()
NATROTA-6MC-IVD

  • Norovirus nucleic acid IVD, control
The NATtrol™ RSV Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ RSV Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ RSV Positive Control
In Commercial Distribution

  • 01220000260092 ()
NATRSV-6C-IVD

  • Respiratory syncytial virus (RSV) nucleic acid IVD, control
"Methyl Green-Pyronin-Y Stain Solution is intended for used in differentiating DNA and RNA in tissue sections for the diagnosis of general pathology specimens. The reaction is based upon the competition between the slow staining, but doubly charged, methyl green and the more rapidly staining, singly charged pyronin Y. Methyl green has two cationic charged groups that become linked to the phosphate moieties in the DNA. The pyronin Y displaces the methyl green from all sites of linkage except where its double charge gives it a selective advantage (acidic polymer such as DNA). Consequently, the methyl green stains DNA and retains its binding to this substance against the competitive action of pyronin Y. Pyronin Y stains the less polymerized RNA rapidly and displaces methyl green from linkages having smaller polymeric acidic substances (RNA). The reaction is done at pH 4.2 – pH 4.3. The advantage of a low pH is to have the nucleic acids in a charged condition and in their least soluble state."
RICHARD-ALLAN SCIENTIFIC COMPANY
Methyl Green-Pyronin Y Stain Solution
In Commercial Distribution

  • 00673693089210 ()
87011

  • Biological stain IVD
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