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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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Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnostic.
Mirrorme3d, LLC
MTPG
In Commercial Distribution



  • Custom-made orthopaedic/craniofacial surgical guide
The VisionAir 3D Stent (Patient-Specific Silicone Airway Stent) is comprised of a cloud-based software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician non-sterile, to be sterilized before use.
VisionAir Solutions, LLC
1
In Commercial Distribution

0010-0126

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
DASSE Urology Drain Bags Vinyl Sterile Fits Hoop Style Urology Frames 10 per Case
TIDI PRODUCTS, LLC
26894
Not in Commercial Distribution

  • 10618125157447 ()
  • 00618125157440 ()
  • 01618125157449 ()
26894

  • Urological fluid funnel, sterile
Medtronic Navigation Inc. Mouse Covers Clear Polyethylene Sterile 1in x 1in x 1in 15 per Case
TIDI PRODUCTS, LLC
24993
Not in Commercial Distribution

  • 10618125152367 ()
  • 00618125152360 ()
  • 01618125152369 ()
24993

  • Medical equipment/instrument drape, single-use
Effective treatment for scar 1. Maintain proper moist environment 2. Support and close the wound 3. Tissue well arrayed, reduce scar proliferation.
TRONJEN MEDICAL TECHNOLOGY INC.
SH2106
In Commercial Distribution

  • 04719884330207 ()
  • 04719884330252 ()
  • 04719884330351 ()
  • 04719859642052 ()

  • Length: 21 Centimeter
  • Width: 6 Centimeter
SH2106

  • Scar-management dressing, single-use
Effective treatment for scar 1. Maintain proper moist environment 2. Support and close the wound 3. Tissue well arrayed, reduce scar proliferation.
TRONJEN MEDICAL TECHNOLOGY INC.
SH0505
In Commercial Distribution

  • 04719884330221 ()
  • 04719884330245 ()
  • 04719884330344 ()
  • 04719859642045 ()

  • Length: 5 Centimeter
  • Width: 5 Centimeter
SH0505

  • Scar-management dressing, single-use
Effective treatment for scar 1. Maintain proper moist environment 2. Support and close the wound 3. Tissue well arrayed, reduce scar proliferation.
TRONJEN MEDICAL TECHNOLOGY INC.
SH1206
In Commercial Distribution

  • 04719884330214 ()
  • 04719884330238 ()
  • 04719884330337 ()
  • 04719859642038 ()

  • Length: 12 Centimeter
  • Width: 6 Centimeter
SH1206

  • Scar-management dressing, single-use
Hydration healing for wounds 1. absorbing exudate (reduce the number of dressing changes, to avoid interference with woundhealing) 2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama) 3. Perfect conformity (Conform to wound’sfigure perfectly, patients feel comfortable in their daily movements)
TRONJEN MEDICAL TECHNOLOGY INC.
HW0505
In Commercial Distribution

  • 04719884330153 ()
  • 04719884330122 ()
  • 04719884330320 ()
  • 04719859641925 ()

  • Length: 5 Centimeter
  • Width: 5 Centimeter
HW0505

  • Scar-management dressing, single-use
Hydration healing for wounds 1. absorbing exudate (reduce the number of dressing changes, to avoid interference with wound healing) 2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama) 3. Perfect conformity (Conform to wound’s figure perfectly, patients feel comfortable in their daily movements)
TRONJEN MEDICAL TECHNOLOGY INC.
HW1206
In Commercial Distribution

  • 04719884330146 ()
  • 04719884330115 ()
  • 04719884330313 ()
  • 04719859641918 ()

  • Length: 12 Centimeter
  • Width: 6 Centimeter
HW1206

  • Scar-management dressing, single-use
Hydration healing for wounds 1. absorbing exudate (reduce the number of dressing changes, to avoid interference with wound healing) 2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama) 3. Perfect conformity (Conform to wound’s figure perfectly, patients feel comfortable in their daily movements)
TRONJEN MEDICAL TECHNOLOGY INC.
HW2106
In Commercial Distribution

  • 04719884330139 ()
  • 04719884330108 ()
  • 04719884330306 ()
  • 04719859641901 ()

  • Length: 21 Centimeter
  • Width: 6 Centimeter
HW2106

  • Scar-management dressing, single-use
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