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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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InnoVoyce VYLO Eye Safety Filter Zeiss
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812104 ()
ASY-300144

  • General/multiple surgical diode laser system
931
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008324 ()
991067S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
930
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008263 ()
991066S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Light Weight Wheelchair
Bowhead Design Corporation
A
In Commercial Distribution

  • 00860013500900 ()


  • Push-rim manual wheelchair, non-bariatric
The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wave (CW) mode or a pulsed wave (PW) mode at manufacture (not programmable by the user). The Reprieve by Regenesis SWD device includes a base control unit, one or two treatment applicators, and an external power supply. The base control unit and treatment applicator(s) are enclosed in an injection-molded case made of medical grade poly carbonate. The treatment applicator(s) and power supply are attached to the base control unit. When not in use, the control unit acts as its own carrying case with the treatment applicators stored a slot in the Control Unit, the power supply stored in an attached pouch behind the control unit, and the treatment applicator cables stored using an attached cable management loop. The Reprieve by Regenesis SWD device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Regenesis Biomedical, Inc.
A
In Commercial Distribution

  • 00868924000038 ()


  • Short-wave diathermy treatment system, home-use
Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution

  • 15430002734023 ()
  • 05430002734026 ()


  • Instrument/analyser specimen/reagent container carrier IVD
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450008772 ()
  • 00884450008775 ()

  • Introducer French Size (F)-5F
  • Needle Gauge (G)-21G
  • Introducer Length (cm)-10 cm (4")
  • Guide Wire Diameter (OD)-0.018" (0.46 mm)
MAK505-PED

  • Vascular dilator, single-use
The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 04250972300134 ()
013400562

  • Diagnostic spirometer, professional
Automated device stand designed to support, position, trigger, and retrieve results from ophthalmic diagnostic equipment during self-administered eye and health assessments in settings where clinical support is available if needed.
EYECHEQ INC.
A
In Commercial Distribution

  • G699Q90630 ()
Q9063

  • Static ophthalmic equipment stand, electrically-adjusted
Vista Clean multi-purpose contact lens solution cleans, rinses, disinfects, stores, and conditions contact lenses. Vista Clean is compatible for use with any lens type including RGP lenses, scleral lenses, hybrid lenses, and soft lenses including silicone hydrogel.
Nomax, Inc.
A
In Commercial Distribution

  • 00351801021030 ()
  • 00351801021047 ()
AH-3665-00000

  • Multi-purpose soft/rigid contact lens solution
  • Multi-purpose rigid contact lens solution
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