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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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Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.
MERIDIAN BIOSCIENCE, INC.
618096
In Commercial Distribution

  • 00840733101717 ()
618096

  • Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA)
Description: Lancet, Push Button Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site and press the push-button to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
SVS LLC
7572
In Commercial Distribution

  • 10811220030398 ()
  • 00811220030391 ()

  • 23G x 1.8mm
7572

  • Blood lancing device tip
Lancet, Pressure, 30G x 1.5mm, Green, 100/bx 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
SVS LLC
7553
In Commercial Distribution

  • 10811220030374 ()
  • 00811220030377 ()

  • 30G x 1.5mm
7553

  • Blood lancing device tip
Lancet, Pressure, BLUE Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
SVS LLC
7552
In Commercial Distribution

  • 10811220030367 ()
  • 00811220030360 ()

  • 25G x 1.8mm, Blue, 100/bx
7552

  • Blood lancing device tip
Color: Pink Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
SVS LLC
7551
In Commercial Distribution

  • 00811220030353 ()
  • 10811220030350 ()

  • 21G Needle x 2.0 mm Depth
7551

  • Blood lancing device tip
The GREEN LASER PHOTOCOAGULATOR SYSTEM GYC-1000 is an ophthalmological photocoagulation system using a solid state laser (green laser beam) with a wavelength of 532nm. Like conventional laser photocoagulation systems, this system is used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. Since the GYC-1000 uses a diode laser as its pumping light source, the efficient oscillation of the 532nm laser beam can be obtained. As the GYC-1000 can be used with various kinds of delivery units, the system can be applied to transpupillary photocoagulation using the slit lamp or indirect ophthalmoscope, and to intraocular photocoagulation using the endophotocoagulation probe.
NIDEK CO.,LTD.
GYC-1000
In Commercial Distribution

  • 04987669100202 ()


  • General/multiple surgical frequency-doubled solid-state laser system
Description: Lancet, Push Button, 28G x 1.5mm, Purple Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site and press the push-button to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
SVS LLC
7573
In Commercial Distribution

  • 10811220030404 ()
  • 00811220030407 ()

  • 28G x 1.5mm
7573

  • Blood lancing device tip
Description: Lancet, Push Button, 17G x 2.0mm, Yellow, 100/bx Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site and press the push-button to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
SVS LLC
7571
In Commercial Distribution

  • 10811220030381 ()
  • 00811220030384 ()

  • 17G x 2.0mm
7571

  • Blood lancing device tip
Kit Contains: (T0E15-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R166) Explorer 5 (R245) Mirror Handle (Cone-Socket) (R283) IPC- Non Coated (R286) G2 Thin Composite (R287) G3 Thin Composite (R363S) 113 Straight Serrated Cord Packer (R375) Mixing Spatula/Applicator (R386) 38-39 Excavator (T040) Tweezers COLLEGE (T046) Articulating Paper Forceps MILLER (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T319) Bur Block (T800) IRIS Scissors, curved
PDT, INC.
R984 Composite & Crown Prep Kit
In Commercial Distribution

  • 00813677024503 ()
R984

  • Suture scissors
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Dental spatula, reusable
  • Dental mirror, reusable
  • Manual non-rotary dental instrument handle
  • Dental restoration carver, amalgam, reusable
  • Gingival retraction cord packing tool
  • Dental irrigation/aspiration syringe
  • Dental excavator, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Structure: composed of optical imaging system, control system and display. Working principle: AUTO REF/KERATOMETER is to use infrared fundus reflex phase method, by launching a specific wavelength beam of infrared light, through the examiner cornea, lens and so on, finally projected onto the retina eyeball, then reflected back to the corresponding optical system, absorb the image by image sensor, after image processing, signal processing, calculate the ball lens diopter, axial column lens dioptre, column mirror, An instrument used to determine the refractive state of the human eye. AUTO REF/KERATOMETER can move in X axis, Y axis and Z axis at the same time, with 3D automatic eye tracking function.
Ningbo Ming Sing Optical R & D Co., Ltd.
ARK-910
In Commercial Distribution

  • 06971821402127 ()


  • Automated ophthalmic refractometer
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