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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Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Pentagon Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
250cm2 Meshed Burn
In Commercial Distribution

  • 05694310960670 ()
  • 05694310960687 ()

  • Length: 250 Centimeter
  • Width: 250 Centimeter
50202M24D0D

  • Animal-derived wound matrix dressing
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Mesh ratio 2:1 Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
7x20 Meshed Burn
In Commercial Distribution

  • 05694310961127 ()
  • 05694310961110 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202N21D0D

  • Animal-derived wound matrix dressing
CUSA® Clarity Ultrasonic Surgical Aspirator System
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7000
In Commercial Distribution

  • 10381780126232 ()
C7000

  • Soft-tissue ultrasonic surgical system
The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation. Model 3020-10 provides a 2 cm x 3.5 cm gauze, in an 8 cm x 10 cm adhesive dressing
Semler Technologies, Inc.
3020-20
In Commercial Distribution

  • 10815614020828 ()
  • 20815614020825 ()
  • 30815614020822 ()
480-3020-20

  • Chitosan haemostatic agent, professional, non-bioabsorbable
CUSA® Clarity Torque Wrench
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7601EA
In Commercial Distribution

  • 10381780466406 ()
C7601EA

  • Ultrasonic surgical system torque wrench, single-use
CUSA® Clarity Nosecone
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7523EA
In Commercial Distribution

  • 10381780466383 ()

  • 23kHz Ultrasonic Frequency
C7523EA

  • Ultrasonic surgical system adaptor, single-use
CUSA® Clarity Bone Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7420SEA
In Commercial Distribution

  • 10381780466369 ()
C7420SEA

  • Hard-tissue ultrasonic surgical system handpiece tip
CUSA® Clarity Tough Tissue Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7418SEA
In Commercial Distribution

  • 10381780466352 ()
C7418SEA

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Clarity MacroTip™
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7405SEA
In Commercial Distribution

  • 10381780466345 ()
C7405SEA

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Clarity Standard Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7401SEA
In Commercial Distribution

  • 10381780466338 ()
C7401SEA

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
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