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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 FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011271 ()
FL12-60

  • HLA class I & II antibody screening IVD, kit, multiplex
The ZEUS AtheNA Multi-Lyte® ANA-II Plus Test System is intended for the semi-quantitative detection of IgG class antibody to eight separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum, and the qualitative detection of IgG class antibody to ANA. The test system is intended to be used as an aid in the diagnosis of various systemic autoimmune disorders. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
A21101
In Commercial Distribution

  • 00845533000017 ()
A21101

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
The WAM700 is a multifunctional ophthalmic device. The machine is a combination of 5 technologies : - Shack Hartmann technology : to measure both low and high order aberrations of the eye, to measure refraction. - Placido disks : for keratometry and for corneal topography measurement. - Non-contact tonometer. - Scheimpflug image : for anterior chamber analysis (pachymetry, irido corneal angle). - Retro illumination : for detection of opacity. Measurement is fully automatic using image processing software and fully automated motors for centering and focusing. The machine includes a fixation target with automatic fogging for accommodation control.
ESSILOR INTERNATIONAL
WAM700
In Commercial Distribution

  • 03615020000380 ()


  • Corneal topography system analyser
  • Corneal topography system
  • Automated ophthalmic refractometer
  • Bench-top keratometer
  • Ophthalmic tonometer, line-powered
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV330
In Commercial Distribution

  • 00865064000157 ()


  • Electrocardiography telemetric monitoring system
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV350
In Commercial Distribution

  • 00860008259233 ()


  • Electrocardiography telemetric monitoring system
The Actua Knee Hydraulic is a polycentric hydraulic knee joint with stance flexion feature and interchangeable spring extension assist. The stance flexion can be tuned infinitely, which ensures optimal comfort during loading response. The patented horizontal hydraulic cylinder contributes to the compact size of this hydraulic knee joint. In addition, maintenance is easy with the innovative oil-refill system.
CYPRESS ADAPTIVE, LLC
CA603-PHY
In Commercial Distribution

  • 00850013242320 ()
CA603-PHY

  • Polycentric mechanical knee prosthesis
SafeWash™ Saline is a sterile first-aid, multi-use jet lavage for wound dressing irrigation and wound cleansing. SafeWash™ Saline wound wash is intended for: moistening and lubricating absorbent wound dressings; cleansing wounds, scrapes and minor burns; flushing and cleansing wounds of exudate, loose necrotic tissue, and foreign material such as dirt and debris. Contains 0.9% Sodium Chloride Solution.
DERMARITE INDUSTRIES LLC
00245
In Commercial Distribution

  • 00714196245076 ()
  • 10714196245073 ()


  • Wound irrigation sterile saline
The Fixation screw is a cannulated titanium alloy screw of 7.5mm diameters partially threaded and decreased thread at the head, allowing optimal compression. The screw has a self-drilling and self-tapping screw tip. These features enable its use in totally intra-osseous fixation. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered sterile.
NEWDEAL
111820SND
In Commercial Distribution

  • 10381780047308 ()
  • M248111820SND1 ()

  • 7.5mm diam. x 120mm length
111820SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The Fixation screw is a cannulated titanium alloy screw of 7.5mm diameters partially threaded and decreased thread at the head, allowing optimal compression. The screw has a self-drilling and self-tapping screw tip. These features enable its use in totally intra-osseous fixation. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered sterile.
NEWDEAL
111815SND
In Commercial Distribution

  • 10381780047292 ()
  • M248111815SND1 ()

  • 7.5mm diam. x 115mm length
111815SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The Fixation screw is a cannulated titanium alloy screw of 7.5mm diameters partially threaded and decreased thread at the head, allowing optimal compression. The screw has a self-drilling and self-tapping screw tip. These features enable its use in totally intra-osseous fixation. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered sterile.
NEWDEAL
111810SND
In Commercial Distribution

  • 10381780047285 ()
  • M248111810SND1 ()

  • 7.5mm diam. x 110mm length
111810SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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