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 Handpiece
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7036RR
In Commercial Distribution

  • 10381780357483 ()
C7036RR

  • Soft-tissue ultrasonic surgical system handpiece, reusable
CUSA® Clarity 36kHz Curved Extended Standard Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7414S
In Commercial Distribution

  • 30381780126366 ()
  • 10381780126362 ()
C7414S

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Clarity Specimen Trap (Sock Insert)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7550
In Commercial Distribution

  • 10381780126478 ()
  • 00381780126471 ()
C7550

  • Surgical suction system collection container, single-use
CUSA® Clarity 36kHz Curved Extended ShearTip™
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7417SEA
In Commercial Distribution

  • 10381780126454 ()
C7417SEA

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Clarity 36kHz Curved Extended MicroTip™ Plus
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7415SEA
In Commercial Distribution

  • 10381780126447 ()
C7415SEA

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Clarity 36kHz Curved Extended Standard Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7414SEA
In Commercial Distribution

  • 10381780126430 ()
C7414SEA

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