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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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VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
Alafair Biosciences, Inc.
VTP-2201
In Commercial Distribution

  • B454VTP22010 ()

  • Total Volume: 1 Milliliter
  • Length: 2 Inch
  • Width: 2 Inch
  • Length: 5 Centimeter
  • Width: 5 Centimeter
VTP-2201

  • Nerve guide, synthetic polymer, bioabsorbable
  • Tendon spacer
Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigation during endoscopy helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Mini Pillow is designed for controlled irrigation through an endoscope or accessory during urological procedures.
WISMED PL SP Z O O
1
In Commercial Distribution

  • 06009900408439 ()
  • 16009900408436 ()
  • 36009900408430 ()


  • Surgical irrigation tubing set, single-use
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
15cc
In Commercial Distribution

  • B4474415000STR0 ()
44-150-00-STR

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOREVIVE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOREVIVE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
15cc
In Commercial Distribution

  • B4474415000REV0 ()
44-150-00-REV

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
15cc
In Commercial Distribution

  • B4474415000BSI0 ()
44-150-00-BSI

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000STR0 ()
44-100-00-STR

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOREVIVE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOREVIVE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000REV0 ()
44-100-00-REV

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOINJECT™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOINJECT™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000INJ0 ()
44-100-00-INJ

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000BSI0 ()
44-100-00-BSI

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4474405000STR0 ()
44-050-00-STR

  • Bone matrix implant, synthetic, non-antimicrobial
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