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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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Biowy Freezing Bag - 00851739007019

Biowy Freezing Bag FB250, Max Volume: 250 mL
Biowy Corporation
FB250
In Commercial Distribution

  • 00851739007019 ()
  • 00851739007231 ()


  • Blood/tissue storage/culture container

Biowy Freezing Bag - 00851739007002

Biowy Freezing Bag FB50, Max Volume: 50 mL
Biowy Corporation
FB50
In Commercial Distribution

  • 00851739007002 ()
  • 00851739007187 ()


  • Blood/tissue storage/culture container

Symphony™ Proliferative Bioscaffold - 09421907331577

Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular matrix.
AROA BIOSURGERY LIMITED
CM03HA050R
In Commercial Distribution

  • 09421907331577 ()

  • 10 cm x 5 cm
CM03HA050R

  • Animal-derived wound matrix dressing

Symphony™ Proliferative Bioscaffold - 09421907331553

Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular matrix.
AROA BIOSURGERY LIMITED
CM03HA035R
Not in Commercial Distribution

  • 09421907331553 ()

  • 7 cm x 5 cm
CM03HA035R

  • Animal-derived wound matrix dressing

Celox Rapid Z-Fold Gauze - 15060206630281

Hemostatic Z-Fold Gauze. Dressing indicated for temporary external use to control moderate to severe bleeding. For use by trained emergency responders.
MEDTRADE PRODUCTS LIMITED
FG08839011
In Commercial Distribution

  • 15060206630281 ()
  • 75060206630283 ()

  • 5 feet x 3 inches
FG08839011

  • Chitosan haemostatic agent, professional, non-bioabsorbable

AVITA - 00810125742095

No Description
Stedical Scientific, Inc.
PDC 2.5 x 5
Not in Commercial Distribution

  • 10810125742092 ()
  • 00810125742095 ()
  • 20810125742099 ()


  • Animal-derived wound matrix dressing

AVITA - 00810125740022

No Description
Stedical Scientific, Inc.
PDC 2.5 x 5
In Commercial Distribution

  • 00810125740022 ()
  • 10810125740029 ()
  • 20810125740026 ()
C1250500

  • Animal-derived wound matrix dressing

Simpurity - 00856253007194

Silver PU Foam with Silicone 4 x 5 inches (Each)
SAFE N' SIMPLE LLC
SNS74445
In Commercial Distribution

  • 00856253007194 ()

  • Length: 5 Inch
  • Height: 4 Inch
SNS74445

  • Wound-nonadherent dressing, absorbent, antimicrobial

Tenex Health TX® - 00857156006260

Fuse Set, 5 X 20, 250V, T5A (Set of 2)
TENEX HEALTH, INC.
430-2215-002
In Commercial Distribution

  • 00857156006260 ()
430-2215-002

  • Ultrasonic suction system

Silverlon Antimicrobial Wound Dressing - 00857278000467

IV/Catheter Dressing 5/8 in Lifesavers with 1.5mm access
ARGENTUM MEDICAL, LLC
IVCD-MINI
In Commercial Distribution

  • 10857278000464 ()
  • 00857278000467 ()


  • Vascular catheterization support/maintenance kit, non-medicated
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