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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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The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
TELA BIO, INC.
R20143-0820P
In Commercial Distribution

  • 00856072005050 ()

  • Length: 8.5 Centimeter
  • Width: 20 Centimeter
R20143-0820P

  • Extra-gynaecological surgical mesh, biologic-polymer composite
ClearFit Retrosigmoid Small
LONGEVITI NEURO SOLUTIONS LLC
171733
In Commercial Distribution

  • 00855113008753 ()


  • Cranial resinous compound
ClearFit complex for international sales
LONGEVITI NEURO SOLUTIONS LLC
991714
In Commercial Distribution

  • 00855113008739 ()


  • Cranial resinous compound
ClearFit Retrosigmoid Large
LONGEVITI NEURO SOLUTIONS LLC
171734
In Commercial Distribution

  • 00855113008586 ()


  • Cranial resinous compound
ClearFit Posterior Fossa Plate
LONGEVITI NEURO SOLUTIONS LLC
171731
In Commercial Distribution

  • 00855113008579 ()


  • Cranial resinous compound
InvisiShunt Implant (OP4001)
LONGEVITI NEURO SOLUTIONS LLC
OP4001
In Commercial Distribution

  • 00855113008449 ()


  • Polyethylene craniofacial tissue reconstructive material
InvisiShunt Cutting Guide (OP5002)
LONGEVITI NEURO SOLUTIONS LLC
OP5002
In Commercial Distribution

  • 00855113008432 ()


  • Polyethylene craniofacial tissue reconstructive material
InvisiShunt Implant (OP5001)
LONGEVITI NEURO SOLUTIONS LLC
OP5001
In Commercial Distribution

  • 00855113008425 ()


  • Polyethylene craniofacial tissue reconstructive material
InvisiShunt Implant Kit (OP5001/OP5002)
LONGEVITI NEURO SOLUTIONS LLC
OP5000
In Commercial Distribution

  • 00855113008418 ()


  • Polyethylene craniofacial tissue reconstructive material
InvisiShunt Cutting Guide (OP4002)
LONGEVITI NEURO SOLUTIONS LLC
OP4002
In Commercial Distribution

  • 00855113008401 ()


  • Polyethylene craniofacial tissue reconstructive material
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