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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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Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Electrolarynx
Freudenberg Medical, LLC
PK 2104
In Commercial Distribution

  • 00848253003436 ()


  • Transcervical artificial larynx
  • Tracheostoma shower shield
  • Tracheostomy base plate, reusable
  • Removable ambulatory appliance skin-adherent patch
  • Heat/moisture exchanger, single-use
  • Laryngectomy tube, non-sterile
  • Tracheostomy tube neck holder, reusable
FAC-3 - Heba Fire & Safety
Certified Safety Manufacturing, Inc.
K613-002
In Commercial Distribution

  • 00766588130026 ()
K613-002

  • Non-woven gauze roll/sheet
  • Non-rebreathing valve, single-use
  • Adhesive bandage
  • Eye pad
  • Wound-nonadherent dressing, absorbent, non-antimicrobial
  • First aid kit, medicated
  • Non-woven gauze pad
  • HLA-B56 (B22) tissue typing IVD, antibody
  • Dressing-fixation skin adhesive tape, non-silicone
Hydrogel Excellent viscosity Clean, greaseless formulation Indications: Use for partial to full thickness wounds, including pressure and stasis ulcers, first- and second-degree burns, lacerations, cuts, abrasions, skin irritations, post-operative incisions, and conditions with periostomal care. Directions for use: Cleanse wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Apply gel approximately 1/4-inch thick to wound bed. Cover with an appropriate secondary dressing. Repeat as often as necessary to keep wound moist. Caution: If condition worsens or does not improve within 10 to 14 days, consult a physician. For external use only. Ingredients: Water, aloe barbadensis leaf juice, glycerin, sorbitol, carbomer, triethanolamine, allantoin, methylparaben, disodium EDTA, imidazolidinyl urea Store at ambient temperature.
Cardinal Health 200, LLC
HG1OZ
In Commercial Distribution

  • 10888499001350 ()
  • 00888499001353 ()
HG1OZ

  • Wound hydrogel dressing, non-sterile
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution

  • 04987669100530 ()


  • Optical pachymeter
  • Direct ophthalmoscope, line-powered
HANDPIECE 1897201 STRAIGHTSHOT III
MEDTRONIC XOMED, INC.
1897201
Not in Commercial Distribution

  • 00681490693950 ()


  • Multi-purpose surgical power tool system, line-powered
HANDPIECE 1897200T IGS MAGNUM II EN
MEDTRONIC XOMED, INC.
1897200T
Not in Commercial Distribution

  • 00681490693943 ()


  • Multi-purpose surgical power tool system, line-powered
ASTM Level 3 Surgical Mask - Box of 50 -
Taiji Medical Supplies Inc.
A1
In Commercial Distribution

  • 10860007355902 ()
  • 00860007355905 ()
  • 00860007355950 ()

  • Length: 175 Millimeter
  • Width: 95 Millimeter
16752

  • Surgical/medical face mask, single-use
5.0 mm Locking Screw 75 mm Length
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
LSB5-075
In Commercial Distribution

  • 00856719002992 ()

  • Outer Diameter: 5.0 Millimeter
LSB5-075

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
5.0 mm Locking Screw 70 mm Length
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
LSB5-070
In Commercial Distribution

  • 00856719002985 ()

  • Outer Diameter: 5.0 Millimeter
LSB5-070

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
5.0 mm Locking Screw 65 mm Length
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
LSB5-065
In Commercial Distribution

  • 00856719002978 ()

  • Outer Diameter: 5.0 Millimeter
LSB5-065

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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