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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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Defender - 00863342000318

The Defender Room Air Cleaner ("Defender") is a portable, mechanical air filtration system designed for single use int he home environment. It is configured as a circular unit with a protective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiency and particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses and odors. During operation, air is drawn into the lower assembly, passes through the upper assembly providing a 360-degree flow of air. The unit is equipped with a scent generator powered by a small heating element. Outlet filtered air passes through the scent generator and out from the top of the unit. The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron in size. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, mold and pet allergens. The Defender is also intended to remove Tobacco smoke and other household odors.
Health Mor At Home Cbp
D11NA
In Commercial Distribution

  • 00863342000318 ()


  • High-efficiency filter air cleaner, mobile

At Ease - 00834533000592

No Description
AL-BAD MASSUOT YITZHAK LTD
BCNAEZCSR02
Not in Commercial Distribution

  • 00834533001490 ()
  • 00834533000592 ()
  • 10834533000599 ()

  • Absorbency


  • Absorbent underpad, non-antimicrobial, single-use

TimeWalker AT - 03830054237629

The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
FOTONA d.o.o.
M021-5AF/1
In Commercial Distribution

  • 03830054237629 ()


  • Dental solid-state laser system
  • Dermatological solid-state laser system
  • Multi-modality skin surface treatment system generator
  • General/multiple surgical solid-state laser system

TimeWalker AT - 03830054230507

The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
FOTONA d.o.o.
M021-5AF/1
Not in Commercial Distribution

  • 03830054230507 ()


  • Dental solid-state laser system
  • Dermatological solid-state laser system
  • Multi-modality skin surface treatment system generator
  • General/multiple surgical solid-state laser system

Lightwalker AT - 03830054230194

The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
FOTONA d.o.o.
M021-5AF/1
Not in Commercial Distribution

  • 03830054230194 ()


  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
  • Dental solid-state laser system

AT Obturator - 10810190010171

No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
E
In Commercial Distribution

  • 10810190010171 ()
at555200tr

  • Arthroscopic surgical procedure kit, non-medicated, reusable

AT 030 - 04049471090260

he AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagnosis, and aid in the management of glaucoma.
Carl Zeiss Meditec AG
AT 030
In Commercial Distribution

  • 04049471090260 ()


  • Ophthalmic examination slit lamp

At Ease - 00075289623561

No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESUWS14
Not in Commercial Distribution

  • 10075289623568 ()
  • 00075289623561 ()
  • 00834533001766 ()

  • Absorbency


  • Incontinence pants, single-use

At Ease - 00075289621925

No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESUWS20
Not in Commercial Distribution

  • 10075289621922 ()
  • 00075289621925 ()
  • 00834533001759 ()

  • Absorbency


  • Incontinence pants, single-use

At Ease - 00075289621710

No Description
AL-BAD MASSUOT YITZHAK LTD
BUSAESUWS18
Not in Commercial Distribution

  • 10075289621717 ()
  • 00075289621710 ()
  • 00834533001742 ()

  • Absorbency


  • Incontinence pants, single-use
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