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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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HybenX OTD Syringe (2-Pack)
BICON, LLC
103-2001
In Commercial Distribution

  • 00813110027337 ()
  • 00813110027825 ()
103-2001

  • Root canal cleaning solution
Collagen wound dressing
NOVABONE PRODUCTS, LLC
NA2210
In Commercial Distribution

  • 00813909011479 ()
  • 00813909010472 ()

  • Depth: 1 Millimeter
  • Width: 2.5 Centimeter
  • Length: 7.5 Centimeter
NA2210

  • General oral wound dressing, animal-derived
Collagen wound dressing
NOVABONE PRODUCTS, LLC
BH2210-S
In Commercial Distribution

  • 00813909010588 ()
  • 00813909010595 ()

  • Depth: 1 Millimeter
  • Width: 25 Millimeter
  • Length: 75 Millimeter
BH2210-S

  • General oral wound dressing, animal-derived
Collagen wound dressing
NOVABONE PRODUCTS, LLC
BH2200-S
In Commercial Distribution

  • 00813909010564 ()
  • 00813909010571 ()

  • Width: 10 Millimeter
  • Length: 20 Millimeter
BH2200-S

  • General oral wound dressing, animal-derived
Collagen wound dressing
NOVABONE PRODUCTS, LLC
BH2210
In Commercial Distribution

  • 00813909010267 ()
  • 00813909010540 ()

  • Width: 25 Millimeter
  • Depth: 1 Millimeter
  • Length: 75 Millimeter
BH2210

  • General oral wound dressing, animal-derived
Collagen wound dressing
NOVABONE PRODUCTS, LLC
BH2200
In Commercial Distribution

  • 00813909010250 ()
  • 00813909010533 ()

  • Width: 10 Millimeter
  • Length: 20 Millimeter
BH2200

  • General oral wound dressing, animal-derived
CUSA® NXT Contamination Guard
INTEGRA LIFESCIENCES (IRELAND) LIMITED
NXT00005
Not in Commercial Distribution

  • 10381780039525 ()
  • 00381780039528 ()
  • M433NXT000051 ()
NXT00005

  • Soft-tissue ultrasonic surgical system
The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and Reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523243
Not in Commercial Distribution

  • M610152324315 ()
  • 10381780039501 ()
  • 00381780039504 ()

  • 35kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Integra Lifesciences Corporation
58105
In Commercial Distribution

  • M269581051 ()
  • 10381780032359 ()
  • 00381780032352 ()

  • Width: 20 Centimeter
  • Length: 25 Centimeter
  • Length: 10 Inch
  • Width: 8 Inch
58105

  • Animal-derived wound matrix dressing
INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Integra Lifesciences Corporation
54105
In Commercial Distribution

  • M269541051 ()
  • 10381780032342 ()
  • 00381780032345 ()

  • Length: 25 Centimeter
  • Width: 10 Centimeter
  • Length: 10 Inch
  • Width: 4 Inch
54105

  • Animal-derived wound matrix dressing
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