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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 portable x-ray system, DHX-70H is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution

  • 18800021800134 ()
  • 08800021800137 ()
  • 28800021800131 ()
  • 38800021800138 ()
  • 48800021800135 ()
  • 58800021800132 ()
  • 68800021800139 ()
  • 78800021800136 ()
  • 88800021800133 ()


  • Diagnostic x-ray system generator, portable
The portable x-ray system, HYBRID Pro is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
HYBRID Pro
In Commercial Distribution

  • 18800021800127 ()
  • 08800021800120 ()
  • 28800021800124 ()
  • 38800021800121 ()
  • 48800021800128 ()
  • 58800021800125 ()
  • 68800021800122 ()
  • 78800021800129 ()
  • 88800021800126 ()


  • Diagnostic x-ray system generator, portable
The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution

  • 18800021800042 ()
  • 08800021800045 ()
  • 28800021800049 ()
  • 38800021800046 ()
  • 48800021800043 ()
  • 58800021800040 ()
  • 68800021800047 ()
  • 78800021800044 ()
  • 88800021800041 ()


  • Diagnostic x-ray system generator, portable
The portable x-ray system, HYBRID C70 is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
HYBRID C70
In Commercial Distribution

  • 18800021800110 ()
  • 08800021800113 ()
  • 28800021800117 ()
  • 38800021800114 ()
  • 48800021800111 ()
  • 58800021800118 ()
  • 68800021800115 ()
  • 78800021800112 ()
  • 88800021800119 ()


  • Diagnostic x-ray system generator, portable
The portable x-ray system, HYBRID S70 is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution

  • 18800021800103 ()
  • 08800021800106 ()
  • 28800021800100 ()
  • 38800021800107 ()
  • 48800021800104 ()
  • 58800021800101 ()
  • 68800021800108 ()
  • 78800021800105 ()
  • 88800021800102 ()


  • Diagnostic x-ray system generator, portable
The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0006
In Commercial Distribution

  • EABA40000061 ()
  • EABA40000060 ()
400-0006

  • Gamma-glutamyltransferase (GGT) IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Glucose IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control,image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.
VISARIS DOO
Avanse DR
In Commercial Distribution

  • 08606102809033 ()


  • Radiological PACS software
Duo kit HYGITECH Reference: HY-09011 The DUO kit is the kit needed for dressing both the surgeon and his assistant. some environment protection is also included, which makes this kit perfect for all kinds of procedures. The kit is composed of 32 items. 4 Polyethylene gloves 1 surgical drape (29.5"x 29.5"/ 75x75cm) 2 Elastic cap handle covers 2 Protective sleeves for tubing (3.5"x 47"/ 8x120cm) 3 non-latex elastic bands 1 Adhesive protective cover for control panel (6.3"x 8.9"/ 16x22cm) 1 surgical cap 2 Bouffant caps 2 tie-on masks 2 Pairs of overshoes 1 surgical brush with nail cleaner 4 Paper hand-towels 1 assistant gown with cotton cuffs 1 surgical gown with cotton cuffs 1 U-shaped surgical drape with adhesive (31.5"x 39"/ 80x100cm) 1 Wrapping paper
HYGITECH
HY-09011
In Commercial Distribution

  • 03615140005302 ()
  • 03615140005296 ()
HY-09011

  • Denture repair kit, professional
The PROTECT kit is HYGITECH’s best selling kit, designed to meet all needs for any type of implant surgery. The kit is composed of 45 items: 4 Polyethylene gloves 1 Instrument table cover (bridge) (90x120cm) 1 Surgical drape (75x75cm) 2 Protective sleeves for tubing (8cmx120cm) 1 Tube support with adhesive 2 Elastic cap handle covers 1 Protective PVC X-ray cover 2 Adhesive protective covers for control panel 3 Non-latex elastic bands 1 Adhesive film 5x80cm 1 Surgical hat 2 Bouffant caps 2 Tie-on masks 3 Pairs of overshoes 2 Sterile brushes with nail cleaner 6 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Assistant gown with cotton cuffs 1 Patient gown with cotton cuffs 1 Surgical drape with aperture and adhesive (70x100cm) 1 U-shaped surgical drape with adhesive (100x150cm) 1 impermeable wrapping paper
HYGITECH
HY-0871
In Commercial Distribution

  • 03615140005265 ()
  • 03615140005258 ()
HY-0871

  • Surgical dressing/drape kit, single-use
The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only. A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing.
Ningbo Youhe Electrical Appliance Technology Co., Ltd
YH-8015
In Commercial Distribution

  • 16957031400044 ()
  • 06957031400047 ()


  • Breast pump, electric
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